FDA Adverse Event Injury Summary report: N

3.5MM LCP DISTAL TIBIA T-PLATE5 HOLES/90MM

MDR report key: 2920325 · Received January 17, 2013

Report

Report Number: 3003506883-2013-00032
Event Type: Injury
Date Received: January 17, 2013
Report Date: December 20, 2012
Manufacturer: SYNTHES ELMIRA
Product Code: HRS
PMA / PMN Number: K080522
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX
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. HOWEVER, A 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. DATE OF IMPLANT UNKNOWN.

Description of Event or Problem · 1

DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2012 IT WAS REPORTED THAT ON AN UNKNOWN DATE A PATIENT WAS INVOLVED IN A MVA AND WAS IMPLANTED WITH A SIX-HOLE SYMPHYSEAL LOCKING PLATE WITH FOUR LOCKING SCREWS. THE PATIENT RETURNED FOR A FOLLOW UP VISIT THREE WEEKS POST IMPLANTATION. AN X-RAY TAKEN ON AN UNKNOWN DATE REVEALED UNSCREWING OF LOCKED SCREWS FROM THE PLATE, AND SCREW WAS PULLING OUT FROM BONE RESULTING FROM COMPLETE LOSS OF REDUCTION. RETROSPECTIVE ANALYSIS REVEALED THAT THE LOCKING SCREWS THAT HAD UNSCREWED AND PULLED OUT IN THE SIX-HOLE PLATE, WERE MISALIGNED WITH THE THREADS OF THE PLATE DURING THEIR SURGICAL INSERTION THIS IS 1 OF 24 REPORTS FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
26034	3.5MM LCP DISTAL TIBIA T-PLATE5 HOLES/90MM	PLATE	HRS	SYNTHES ELMIRA		6857521

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Required Intervention	PLATES, SCREWS