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

Device Problems Material Fragmentation (1261); Migration or Expulsion of Device (1395); Device Dislodged or Dislocated (2923)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Literature article received: ¿this report is being filed after the subsequent review of the following literature article: reference: lebl, d.(2012).In vivo functional performance of failed prodisc-l devices.Spine.Volume 37, pp e1209-e1217.Usa.¿ this article discusses a retrieval analysis of wear modes and fixation of lumbar total disc replacements (tdrs).Explanted prodisc-l tdrs were prospectively collected during a 7-year period between 2005 and 2011 and analyzed.The purpose of the study was to assess the in vivo modes of wear and fixation of lumbar tdr with the prodisc-l device.Nineteen prodisc-l devices from 18 patients were explanted for pain, prothesis subluxation/migration, end plate collapse/subsidence, polyethylene dislodgement, and unknown causes.This report is for device 14.Device 14 was explanted from a (b)(6) male patient.Device 14 was implanted at level l4-l5, the implant size was medium, and the polyethylene size was 12mm.The device was explanted due to the polyethylene inlay being dislodged.The surgeon-reported presentation was that the polyethylene was anterior to l4-l5 disc space (dome facing anterior) and appeared to have a small portion sheared off.Analysis of the explanted device showed posterior burnishing on both components, posterior polyethylene deterioration, backside wear, third party wear from embedded titanium particle (dome), 10% superior component ongrowth, and 10% inferior component ongrowth.This report is 38 of 48 for (b)(4).This report is for an unknown prodisc-l device, unknown part#/lot#.

Manufacturer Narrative

Device was used for treatment, not diagnosis.Additional narrative: this report is for 1 unknown prodisc-l polyethylene inlay /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 was 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: 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: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 4771841
• MDR Text Key: 5776140
• Report Number: 2530088-2015-10257
• 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: 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: 05/14/2015
• 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
• Patient Age: 49 YR