FDA Adverse Event Injury Summary report: N

TI LCP(TM) DISTAL FEMUR PLATE 9 HOLES/236MM-LEFT

MDR report key: 2874750 · Received December 16, 2012

Report

Report Number: 2520274-2012-03798
Event Type: Injury
Date Received: December 16, 2012
Date of Event: September 30, 2008
Report Date: September 21, 2010
Manufacturer: SYNTHES
Product Code: HRS
PMA / PMN Number: K062564
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED OCTOBER 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

Description of Event or Problem · 1

(B)(6) COMPLAINT HANDLING UNIT REPORTED A BROKEN PLATE. SURGERY TOOK PLACE ON (B)(6) 2008, PART NUMBER UNKNOWN AND THE PLATE BROKE. IN (B)(6) 2009, RE-OP STABILIZATION BY MEANS OF A LOCKING COMPRESSION PLATE-DISTAL FEMUR PLATE, BREAKAGE OF LOCKING COMPRESSION PLATE-DISTAL FEMUR PLATE IN (B)(6) 2010, PLATE WAS NOT REMOVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TI LCP(TM) DISTAL FEMUR PLATE 9 HOLES/236MM-LEFT		HRS	SYNTHES

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention