MAUDE Adverse Event Report: SYNTHES USA 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT; IMPLANT,FIXATION DEVICE,CONDYLAR PLATE

Catalog Number 02.124.418

Device Problem Break (1069)

Patient Problem Non-union Bone Fracture (2369)

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2014, the surgeon discovered a broken variable angle (va), locking compression condylar plate (lcp) on a routine clinic visit.The fracture was in a delayed healing non-union state.A revision surgery was completed on (b)(6) 2014 to explant the plate which was removed without incident.It was reported that reamer/irrigator/aspirator (ria) bone graft was harvested from the same femur.It was reported that screws were fully intact.Patient was revised with a zimmer retrograde femoral nail and (ria) bone graft was applied to the non-union site.Surgery was completed successfully without any time delay.The patient is in good condition.This is report 1 of 1 for complaint (b)(4).

Manufacturer Narrative

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: 4.5MM VA-LCP CURVED CONDYLAR PLATE/18 HOLE/370MM/RIGHT
• 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: 3986734
• MDR Text Key: 16556486
• Report Number: 2520274-2014-13001
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2014

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: 02.124.418
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/10/2014
• Initial Date FDA Received: 08/07/2014
• 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 Weight: 98