MAUDE Adverse Event Report: SYNTHES BRANDYWINE; PROTHESIS, INTERVETEBRAL DISC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Pain (1994); Post Operative Wound Infection (2446)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: this report is for an unknown prodisc-l device (polyethylene inlay)/unknown quantity/unknown lot.(b)(6).The investigation could not be completed and no conclusion could be drawn as no device was returned and no lot number or part number were provided.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

This report is being filed after the subsequent review of the following article: zigler et al (2003) lumbar arthroplasty early results using the procdisc ii: a prospective randomized trial of arthroplasty versus fusion.Journal of spinal disorders & techniques, volume 16, pages 352-361.Usa article.This study represents single center data from an fda investigational device exemption (ide) study that prospectively evaluated the safety and efficacy of the prodisc ii.The purpose of this study was to present the 6-month single center data from an fda study comparing total disc arthroplasty using the prodisc ii (spine solutions, (b)(4)) versus circumferential spinal fusion in a prospective randomized fashion.Patients were randomized to either artificial disc replacement or circumferential spinal fusion.Twenty-five patients received artificial disc replacement and 11 patients received circumferential spinal fusion.The average age in the artificial disc replacement was 37.7 years and in the fusion group it was 41.6 years.The patients in the fusion group had a biconvex-shaped femoral ring allograft (synthes, (b)(4)) inserted with a 6.5-mm ao cancellous screw (synthes) used as to prevent anterior migration.Data was collected preoperatively, perioperatively, and at intervals of 6 weeks, 3 months, and 6 months postoperatively.Outcome data collected included the visual analog scale (vas), the oswentry low back pain disability questionnaire (odq), patient satisfaction rates, range of motion, return to work and recreational and ambulatory status.For unidentified patients- one patient had iliac vein laceration that was repaired during the index procedure, one patient had superficial wound infection that resolved after course of oral antibiotics, one patient had sacroiliac joint pain and was treated with steroid injections and chiropractic therapy for partial relief, and two patients developed right leg pain and was treated with neorontin and epidural injections.This is report 4 of 7 for (b)(4).This report is for: unknown number of prodisc-l devices(polyethylene inlay).

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Type of Device: PROTHESIS, INTERVETEBRAL DISC
• Manufacturer (Section D): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4778488
• MDR Text Key: 21850818
• Report Number: 2520274-2015-13778
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PP050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention