MAUDE Adverse Event Report: SYNTHES BRANDYWINE PRODISC-L INF-PL SIZ M 3°; PROSTHESIS, INTERVERTEBRAL DISC

Catalog Number SSX662K

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

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: the surgeon reportedly removed the patients implant on (b)(6) 2014 due to pain and subsidence of the implant.The patient was originally instrumented dese on (b)(6) 2010.In (b)(6) 2011, the patient had a fall resulting in surgery on (b)(6) 2011 to implant a prodisc protese, and remove the dese material posterior.The patient was reported to be doing ¿good¿ until (b)(6) 2011, it is unknown what if anything was done at this time.Reportedly in 2014 the patient was experiencing increased pain and the surgeon removed the prodisc using the prodisc recision set.There was no indication that the implant was loose, the surgeons think that the problem for the patient might be some kind of infection, possibly from an earlier "fall accident" years ago.The implant was removed, and a donor bone implant was put in place.The explanted device surrounding the implant was sent to the laboratory to test for infection, no laboratory results have been submitted with this complaint.This is 2 of 3 reports for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.Patient id reported only as (b)(6).The 510k#: device is not distributed in the united states, but is similar to device marketed in the usa.Without a lot number the device history records review could not be completed.The investigation could not be completed; no conclusion could be drawn, as no product was received.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PRODISC-L INF-PL SIZ M 3°
• 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: 4362591
• MDR Text Key: 20748769
• Report Number: 2530088-2014-10459
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: PP050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SSX662K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2014
• 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