FDA Adverse Event Injury Summary report: N

VERTEX RECONSTRUCTION SYSTEM

MDR report key: 1518899 · Received October 29, 2009

Report

Report Number: 1030489-2009-01005
Event Type: Injury
Date Received: October 29, 2009
Report Date: September 29, 2009
Manufacturer: WARSAW ORTHOPEDIC INC.
Product Code: KWP
PMA / PMN Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 6955506, 510K # K003780 WAS CLEARED IN THE UNITED STATES. MANUFACTURE DATE FOR LOT W05K1513 IS 10/25/2005; MANUFACTURE DATE FOR LOT W07C5119 IS 05/08/2007. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WHO HAD BASILAR IMPRESSION ASSOCIATED WITH RHEUMATISM UNDERWENT A PROCEDURE AT O-C3 USING POSTERIOR FIXATION. IT WAS REPORTED THAT ALL THREE CORTICAL SCREWS FOR THE MIDLINE OC PLATE BACKED OUT. THE PATIENT REPORTEDLY DEVELOPED A MODEST NUMBNESS. A REVISION SURGERY WAS PERFORMED APPROXIMATELY FIVE WEEKS POST OP. DURING THE REMOVING PROCEDURE, IT WAS FOUND THAT THE MIDLINE OC PLATE WAS IMPLANTED NOT AT MIDLINE BUT TOWARD RIGHT. THE PLATE WAS REPLACED. THE SURGEON BELIEVED THAT THERE WAS NOT ANY PROBLEM RELATED TO THE IMPLANTED PRODUCTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VERTEX RECONSTRUCTION SYSTEM	BONE SCREW	KWP	WARSAW ORTHOPEDIC INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	72 YR		Required Intervention	LOT# W07C5119\| BONE SCREW: G6955506, LOT# W05K1513