FDA Adverse Event Injury Summary report: N

LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM

MDR report key: 2895836 · Received January 3, 2013

Report

Report Number: 3003506883-2013-00008
Event Type: Injury
Date Received: January 3, 2013
Report Date: December 5, 2012
Manufacturer: SYNTHES ELMIRA
Product Code: HRS
PMA / PMN Number: K011335
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NV, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IMPLANT DATE REPORTED 2008 OR 2009.

Description of Event or Problem · 1

PATIENT SUFFERED FROM A BOTH BONE FOREARM FRACTURE (BBFF) ON AN UNKNOWN DATE IN 2008 OR 2009. AT THIS TIME, PATIENT WAS IMPLANTED WITH A 3.5 LCP 6-HOLE PLATE, TWO 1/3 TUBULAR LCP PLATES, AND SCREW CONSTRUCT. ON AN UNKNOWN DATE, PATIENT FELL AND REINJURED THE BBFF. PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. SURGEON REMOVED ALL THE HARDWARE FROM THE RADIUS AND THE ULNA AND REDUCED THE FRACTURE. PATIENT WAS REVISED WITH A 3.5 LCP 12-HOLE PLATE ON RADIUS AND A LCP RECON PLATE ON ULNA. NO FURTHER INFORMATION ON THE RECOVERY OR ANTICIPATED TREATMENT WAS AVAILABLE AT THIS TIME. THIS IS 3 OF 14 REPORTS FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
3313	LCP ONE-THIRD TUBULAR PLATE WITH COLLAR 5 HOLES/57MM	TUBULAR PLATE	HRS	SYNTHES ELMIRA		6047968

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR		Required Intervention	PLATE, TUBULAR PLATE, SCREWS