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U.S. Department of Health and Human Services

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

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SYNTHES USA 4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT IMPLANT,FIXATION DEVICE, CONDYLAR PLATE Back to Search Results
Catalog Number 02.124.415
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.

 
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Brand Name4.5MM VA-LCP CURVED CONDYLAR PLATE/14 HOLE/301MM/LEFT
Type of DeviceIMPLANT,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 Key3935622
Report Number2520274-2014-12529
Device Sequence Number1
Product CodeJDP
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 Received07/15/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number02.124.415
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received06/17/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Type of Device Usage Unkown

Patient TREATMENT DATA
Date Received: 07/15/2014 Patient Sequence Number: 1
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