FDA Adverse Event Malfunction Summary report: N

TSRH

MDR report key: 2281845 · Received October 7, 2011

Report

Report Number: 1030489-2011-01281
Event Type: Malfunction
Date Received: October 7, 2011
Report Date: September 8, 2011
Manufacturer: WARSAW ORTHOPEDICS
Product Code: KWP
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 828-090, 510K # K964275 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. DEVICE HISTORY RECORDS FOR THESE LOTS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

Additional Manufacturer Narrative · 1

FILMS WERE SUPPLIED FOR REVIEW WHICH FOUND: EXTREMELY POOR FILMS OF COMPLEX CONSTRUCT WITH PEDICLE SCREWS SEGMENTALLY OVER AT LEAST 6 LEVELS. INTERBODY DEVICES ARE SEEN AT L3, L4, AND BILATERAL CAGES AT L5/S1. RIGHT S1 SCREW AND ROD HAVE DISASSOCIATED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A SPINAL SURGICAL PROCEDURE AT L2-S1 WITH RODS AND VERTEBRAL BODY REPLACEMENTS AT L2-3 AND L3-4 TO TREAT A DEGENERATIVE DISEASE. IT WAS FOUND ON X-RAY THAT THE ROD CAME LOOSE FROM THE S1 SCREW ON THE RIGHT SIDE. FUSION IS COMPLETE AND THE PATIENT IS NOT COMPLAINING OF NEUROLOGIC MANIFESTATION SO A REVISION SURGERY WILL NOT BE PERFORMED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TSRH	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	WARSAW ORTHOPEDICS	NA	W08E0857

Patients

Seq	Age	Sex	Outcome	Treatment
1	00071 YR			VB REPLACEMENT, SCREWS