MAUDE Adverse Event Report: SYNTHES USA 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT; IMPLANT,FIXATION DEVICE, CONDYLAR PLATE

Catalog Number 02.124.415

Device Problem Break (1069)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Event Description

Device report from synthes (b)(4) reports an event in (b)(6) as follows: surgery was performed without any problems on (b)(6), 2013.On (b)(6) 2014, the patient was walking in the street using crutches when he felt a lot of pain.Patient denied fall and was taken to the hospital.The surgeon performed radiographic studies (x-rays) that displayed the plate was broken.Surgery was scheduled for (b)(6), 2014 for the removal of the broken plate.The x-rays showed that the fracture had not yet consolidated.The surgeon made an interfragmentary reduction to give greater stability to the fragments and then proceeded to place the new plate.This report is 1 of 1 for (b)(4).

Manufacturer Narrative

Device was used for treatment, not diagnosis.This report is for one unknown plate/unknown lot.Common device name: additional product codes, hrs, hwc.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.

• Brand Name: 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/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: 3935622
• MDR Text Key: 4536646
• Report Number: 2520274-2014-12529
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 02.124.415
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2014
• 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: 39 YR