MAUDE Adverse Event Report: SYNTHES USA 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.409

Device Problem Break (1069)

Patient Problems Pain (1994); Non-union Bone Fracture (2369); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(6).Unknown when plate broke or non-union started.Additional product code: hwc (b)(4).Device is expected to be returned to synthes manufacturer for evaluation /investigation, but has yet to be received.(b)(4).Subject device has not been received.Without a lot number, the device history record review and 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.

Event Description

It was reported that the patient was implanted with a left 4.5mm va-lcp curved condylar plate on an unknown date in (b)(6) 2015.The patient developed a non-union and eventually the plate broke.Reportedly, the patient had pain associated with the broken plate that was diagnosed by x-ray.The patient was returned to the operating room on (b)(6) 2016 for revision surgery.The broken plate was removed and an 8-hole variable condylar plate left was implanted.The non-union was taken down.The patient received a bone graft with 10cc's demineralized bone matrix (dbx) and a bone stimulator was put in.The plate broke into 2 large pieces that were easily removed, no fragments were generated.No surgical delay was reported.The procedure was successfully completed and the patient's condition was reported stable following the procedure.No additional information is available.This complaint involves 1 device.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Product code changed to jdp.Additional product code: hrs.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Patient weight confirmed and updated.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Device is not expected to be returned for manufacturer review/investigation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/8 HOLE/195MM/LEFT
• Type of Device: IMPLANT,FIXATION DEVICE, CONDYLAR PLATE
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: linda plews ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 5574435
• MDR Text Key: 42568120
• Report Number: 2520274-2016-12073
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK110354
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/13/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 04/27/2016; 05/03/2016; 05/04/2016
• 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
• Patient Age: 74 YR
• Patient Weight: 101