MAUDE Adverse Event Report: SYNTHES BRANDYWINE; PROSTHESIS, INTERVERTEBRAL DISC

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

Patient Problems Headache (1880); Muscle Spasm(s) (1966); Pain (1994); Numbness (2415); No Code Available (3191)

Event Date 11/04/2015

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.The investigation could not be completed and no conclusion could be drawn, as no device was returned and no lot number or part number was provided.(b)(4).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 literature article: janssen, m., et al.(2015).Prodisc-c total disc replacement versus anterior cervical discectomy and fusion for single-level symptomatic cervical disc disease.The journal of bone and joint surgery, vol 97:1738-47.Usa.The purpose of the study was to report the seven-year efficacy and safety outcomes of a randomized controlled trial in which total disc arthroplasty with prodisc-c (pdc) was compared with anterior cervical discectomy and fusion (acdf) for the treatment of single-level cervical degenerative disc disease.It is unknown who manufactured the acdf devices and what devices were used.However, article stated that plate(s) was used.Two hundred and nine patients at 13 sites were randomly treated with pdc (n=103, 55 females, mean age of 42.1) or with acdf (n=106, 54 females, mean age of 43.5).Patients were assessed preoperatively; at 5 weeks and 3, 6, 12, 18, and 24 months postoperative; and then annually until 7 years postoperatively.Radiographic data were obtained and analyzed by radiologists at each visit.The following complications were reported: at 7 years, 12% (9) of the 76 patients in pdc group had taken strong narcotics in the week before follow-up visit.Additionally, 15% (12) of the 79 patients in pdc group had taken muscle relaxants in the week before their follow-up visit.:1 patient had adjacent level degenerative disc disease or degenerative joint disease changes :6 patients had headache.:1 patient had musculoskeletal: neck spasms.:2 patients had numbness: index-level related.:2 patients had numbness: non-index-level related.:1 patient had pain: back and lower extremities.:1 patient had pain: incision site.:5 patients had pain: neck.:2 patients had pain: neck and shoulder.:2 patients had pain: neck and upper extremities.:2 patients had pain: neck and upper extremities with numbness.:2 patients had pain: shoulder.:1 patient had pain: upper extremities with numbness.1 patient had other wound issues.This is report 1 of 2 for com-(b)(4).This report is for an unknown prodisc-c (pdc).

• Type of Device: PROSTHESIS, INTERVERTEBRAL 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: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6247825
• MDR Text Key: 64690324
• Report Number: 2530088-2017-10005
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2017
• 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?: No
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention