MAUDE Adverse Event Report: SYNTHES (USA) 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT; CONDYLAR PLATE FIXATION IMPLANT

Catalog Number 02.124.412

Device Problem Break (1069)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in germany as follows: it was reported a variable angle locking compression plate-condylar plate (va-lcp) broke postoperatively for the second time.This plate was implanted on (b)(6) 2014 and was reported to have discovered to be broken on (b)(6) 2014.The first implant from (b)(6) 2013 was reported to have been fractured and discovered on (b)(6) 2014.This incident has also been documented in the synthes complaint handling system.An image reading of the x-rays was conducted by a medical director from this manufacturer and reported the following: all of the x-rays that were sent were either from (b)(6) 2014 after the reoperation to replace the first broken plate (according to narrative it broke in (b)(6) 2014) or from (b)(6) 2014 before the plate broke for the second time in (b)(6) 2014.There are no broken plates in the x-rays that were sent to us this is report 1 of 1 for (b)(4).

Manufacturer Narrative

Clinical/surgery notes and x-rays sent with this event appear to be relevant to the first broken implant; therefore, clinical report information is not included with this report 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: 4.5MM VA-LCP CURVED CONDYLAR PLATE/12 HOLE/266MM/RIGHT
• Type of Device: CONDYLAR PLATE FIXATION IMPLANT
• 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: 4268678
• MDR Text Key: 5227280
• Report Number: 2520274-2014-14883
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: PK110354
• 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: 10/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/29/2014
• 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: 63