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

Device Problem Fitting Problem (2183)

Patient Problem Limited Mobility Of The Implanted Joint (2671)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following article: käfer et al., (2008) posterior component impingement after lumbar total disc replacement.Spine, volume 33, pages 2444-2449.(b)(4) article.This was an investigational device exemption study of 56 patients with degenerative disc disease or post discectomy-syndrome or a combination of both who were treated between (b)(6) 2000 and (b)(6) 2006 with a total of 66 prodisc-l prostheses implants (synthes, (b)(4)).Forty-six patients received a mono-segmental implantation and 10 patients received bi-segmental implantations.The objective of this study was to assess radiographically segmental angulation and mobility after lumber total disc replacement (tdr), to determine the rate of posterior component impingement, and to investigate the influence of implantation level and mono versus bi-segmental implantations.The average patient age was 40.4±7.5 years, gender ratio (male/female) was 23:33.The segmental angulation and extension was measured twice on standing radiographs (neutral position and maximum extension) using the spike method.The average angulation in the neutral position was 9.9° (±4.8°) and 9.9° (±4.9°) at first and second measurements, respectively.In maximum extension it was 11.3° (±4.9°) and 11° (±4.9°).This report for unidentified patients, 11% (am) and 5% (95% ci) of protheses that showed posterior component impingement in the neutral position.For the 15% (am) and 9% (95% ci) of protheses that showed posterior component impingement in maximum extension.Mobility was maintained in 52 protheses (79%), but only 21 (32%) extended more than 1.4° this is report 3 of 3 for (b)(4).This report is for: unknown number and quantity of prodisc-l devices (polyethylene inlay), unknown lot number.

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for an unknown prodisc-l device(polyethylene inlay), /unknown quantity/unknown lot.Udi # unknown part number; udi is unavailable.(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.

• Type of Device: PROTHESIS, 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4794301
• MDR Text Key: 5830182
• Report Number: 2530088-2015-10405
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: PP050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2015
• 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