FDA Adverse Event Injury Summary report: N

4.5MM CURVED BROAD LCP® PLATE 18 HOLES/336MM

MDR report key: 2903465 · Received January 9, 2013

Report

Report Number: 8030965-2013-00073
Event Type: Injury
Date Received: January 9, 2013
Report Date: December 12, 2012
Manufacturer: SYNTHES GMBH
Product Code: KTT
PMA / PMN Number: K041911
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CO
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. HOWEVER, THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND.

Additional Manufacturer Narrative · 1

THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. THE PLATE IS BROKEN IN HALF AT THE 12TH SCREW HOLE. A BROKEN OFF SCREW HEAD IS JAMMED IN THE 13TH THREADED SCREW HOLE. THE DIMENSIONS WERE AS FAR AS POSSIBLE CHECKED. ALL MEASURED DIMENSIONS PASSED THE SPECIFICATIONS SUCCESSFULLY. THE DHR REVIEW SHOWS THAT THE DEVICE MET THE SPECIFICATIONS AT THE TIME OF MANUFACTURING.

Description of Event or Problem · 1

DURING A SURGERY ON (B)(6) 2012, A PATIENT WAS IMPLANTED WITH A PLATE AND EIGHT SCREWS. PATIENT PRESENTED ON (B)(6) 2012 COMPLAINING OF PAIN, AND X-RAYS REVEALED A BROKEN PLATE. ON (B)(6) 2012, THE HARDWARE, A BROKEN PLATE, BROKEN LOCKING SCREW, AND SEVEN OTHER SCREWS WERE REMOVED. THE PATIENT WAS AND REVISED WITH IDENTICAL PLATE AND SCREWS. ALL PARTS WERE RETURNED. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
10882	4.5MM CURVED BROAD LCP® PLATE 18 HOLES/336MM	4.5MM CURVED BROAD LCP® PLATE 18 HOLES/336MM	KTT	SYNTHES GMBH		2090525

Patients

Seq	Age	Sex	Outcome	Treatment
1	83 YR		Required Intervention	PLATES, SCREWS