MAUDE Adverse Event Report: SYNTHES BRANDYWINE; PROSTHESIS INTERVERTEBRAL DISC

Device Problem Malposition of Device (2616)

Patient Problems Pain (1994); Stenosis (2263); No Code Available (3191)

Event Type  Injury  

Event Description

This report is being filed after the subsequent review of the following journal article: choma, t., et al.(2009).Retrieval analysis of a prodisc-l total disc replacement.J spinal disord tech, volume 22, number 4, pp.290-296.Usa.The study objective was to analyze a previously unreported mode of implant malpositioning, wear mechanisms, and polyethylene locking mechanism, and to study retrieved periprosthetic tissues.The study included a patient who underwent a disc replacement with a prodisc-l prosthesis (12mm, size m) at l5-s1 on an unknown date for unremitting back pain.She reported that she had worsening low back pain postoperatively, and now had significant bilateral posterior thigh pain.Eleven (11) months postoperatively she was still complaining of severe back pain and bilateral posterior thigh and leg pain in s1 distributions.Imaging was taken.The patient was found to have a posteriorly malpositioned implant causing significant spinal canal stenosis and demonstrating radiographic instability and the inferior endplate seemed to be posteriorly malpositioned.Fourteen (14) months postoperatively, the patient underwent a removal of the implant and was revised to an anterior lumbar interbody fusion (alif) with an unknown peek interbody spacer filled with an unknown recombinant human bone morphogenetic protein-2 (rhbmp-2) sponge and an unknown anterior plate.There was no indication these were synthes devices.During the removal procedure, the transperitoneal approach was complicated by three (3) incidental venotomies requiring vascular surgery repair.Six months later, the patient had an apparent solid arthrodesis but still complained of low back pain.Intraoperative tissue samples were collected and an analysis of the implant was conducted.Evidence of burnishing was found on the dome of the core, anterior rim of the core and regions of the backside of the core.Anterior rim impingement resulted in burnishing and localized mile plastic deformation.There was minimal wear and oxidation.Bone ongrowth was found on the superior and inferior endplates.Evidence of early cell degeneration and periprosthetic was also found.This is report 3 of 3 for (b)(4).This report is for an unknown prodisc-l implant, unknown part # / lot #.

Manufacturer Narrative

Choma, t., et al.(2009).Retrieval analysis of a prodisc-l total disc replacement.J spinal disord tech, volume 22, number 4, pp.290-296.This report is for an unknown prodisc-l implant (inferior endplate), unknown quantity / unknown lot.(b)(6).(b)(4).Revision due to inferior endplate posteriorly malpositioned.Tissue samples - evidence of early cell degeneration.Periprosthetic was also found.Three intraoperative venotomies requiring vascular surgery repair.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: 4781994
• MDR Text Key: 22029418
• Report Number: 2530088-2015-10353
• 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: 05/19/2015
• 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: 27 YR