Faculty Bibliography

BACKGROUND CONTEXT/BACKGROUND:Lumbar disc replacement (LDR) is a motion sparing procedure for degenerative disc disease. When compared to lumbar fusion, this procedure may reduce complications, reoperations, operative time, and length of stay. However, the extent of overall complications related to LDR has not been well defined in the literature. PURPOSE/OBJECTIVE:Demonstrate the complication profile of popular LDR implants reported to the Food and Drug Administration (FDA). STUDY DESIGN/METHODS:Retrospective database review. PATIENT SAMPLE/METHODS:Nationwide database of reported complications related to LDR products from patients throughout the country. OUTCOME MEASURES/METHODS:Complications related to LDR. METHODS:Data files from January 1, 2004 to April 1, 2021 were queried using the publicly accessible Manufacturer and User Facility Device Experience (MAUDE) database and Alternative Summary Reporting program. Three LDR ("Charité," "Prodisc-L," and "Activ L") products were analyzed for complications. Data collected included the date the reports were received by the FDA, the type of complication, complication event description, and the source of the report. The complication event description was utilized to determine the completion of the investigation. Entries with insufficient information were excluded. Complications were further divided into two categories, device and non-device related. RESULTS:A total of 431 complication entries were found between January 1, 2004, and April 1, 2021. After screening for duplicates and events with insufficient information there were 284 total complications. The total complications were then further divided into implant and non-implant related. The five most common overall complications were lumbar pain (49 entries, 17.25%), migration of implant (42 entries, 14.78%), polyethylene dislodged (37 entries, 13.0%), insertion of device problem (37 entries, 13.0%), device handling problem (12 entries, 4.22%). The most common implant related complication, along with the number of MAUDE entries for each implant was migration of implant for Charité (n=6); Migration of implant for ActivL (n=24); Polyethylene dislodged for ProdiscL (n=32). Of the 284 total complications analyzed, 86 (30.28%) of the entries were deemed "investigation completed." The majority of reports were submitted from the manufacturer and company representative (66.2%, 14.8 % respectively). There were no entries related to LDR within the Alternative Summary Reporting search. CONCLUSIONS:This study outlined the complications of LDR implants from the MAUDE database which have not always been highlighted in previously published studies. The findings of this study provide insight into the potential targets for improvement in future LDR design and surgical techniques to reduce complications and ensure the safe utilization of these implants.

STUDY DESIGN/METHODS:Database study. OBJECTIVE:The purpose of this study was to use a large, nationwide database to determine prevalence of pediatric spine fractures in the United States, associated injuries, mechanisms of injury (MOI), use of safety devices, and mortality rates. SUMMARY OF BACKGROUND DATA/BACKGROUND:Spinal fractures account for 1% to 2% of pediatric injuries. However, they are associated with significant comorbidities and complications. Motor vehicle accidents (MVAs) are most responsible for increased incidence observed. METHODS:Retrospective review of National Trauma Data Bank between 2009 and 2014 (analysis in 2019) for all vertebral fractures in patients under 18 years of age. Subanalysis included those in MVAs where protective device use data were available. Patient demographics, MOI, geographical and anatomical region of injury, concomitant musculoskeletal/organ injury, protective device usage, hospital length of stay, surgical procedures, and mortality were all analyzed. RESULTS:A total of 34,563 patients with 45,430 fractured vertebrae included. Median age was 15 years. Most fractures (63.1%) occurred in patients aged 15 to 17 years, most frequent MOI was MVA (66.8%), and most common geographic location was the South (38%). Males sustained more spine fractures than females, overall (58.4% vs. 41.6%; P < 0.001) and in MVAs (54.4% vs. 45.6%; P < 0.001). Those in MVAs wearing seatbelts had lower odds of cranial (29.6% vs. 70.4%; odds ratio [OR] = 0.85, 95% confidence interval [CI]: 0.82-0.89; P < 0.001) and thoracic (30.1% vs. 69.9%; OR = 0.88, 95% CI: 0.84-0.91; P < 0.001) organ injury, multivertebral (30% vs. 70%; OR = 0.78, 95% CI: 0.73-0.83; P < 0.001) and concomitant nonvertebral fractures (30.9% vs. 69.1%; OR = 0.89, 95% CI:0.73-0.83; P < 0.001), and 21% lower odds of mortality (29.3% vs. 70.7%; OR = 0.79, 95% CI: 0.66-0.94; P = 0.009). Over 70% of drivers were not restrained during MVA, with majority of seatbelt violations incurred by males, ages 15 to 17, in the South. CONCLUSION/CONCLUSIONS:Over 60% of pediatric spinal fractures occur in children aged 15 to 17 years, coinciding with the beginning of legal driving. MVA is the most common cause and has significant association with morbidity/mortality. Nearly two- thirds pediatric spinal fractures sustained in MVAs occurred without seatbelts. Absence of seatbelts associated with >20% greater odds of mortality. Ensuring new drivers wear protective devices can greatly reduce morbidity/ mortality associated with MVA.Level of Evidence: 3.

Acute motor and sensory axonal neuropathy (AMSAN) is a rare axonal variant of Guillain-Barré syndrome. AMSAN is considered the most severe form of GBS, known for its rapid onset of severe symptoms, and often leading to quadriparesis within 7 days of initial symptom onset. We present a case of a middle-aged Caucasian female who developed AMSAN 2 weeks following an elective spinal surgery. Although rare, GBS has been reported as a complication of surgery. GBS classically presents as ascending motor weakness starting in the lower extremities following a gastrointestinal or upper respiratory tract infection. This patient's GBS manifested slightly differently, with both sensory and motor symptoms of her thoracic region and lower extremities, with no preceding history indicative of infection. To the authors' knowledge, this is the first reported case of AMSAN following spinal surgery. Because of its risk of significant morbidity and mortality, as well as similar presentation to more common spinal postoperative complications, GBS should always be included in the differential diagnosis whenever motor or sensory weakness is observed after spinal surgery.