FDA Adverse Event Malfunction Summary report: N

LIBERTY POSTERIOR SPINAL SYSTEM

MDR report key: 1604044 · Received February 11, 2010

Report

Report Number: 1030489-2010-00163
Event Type: Malfunction
Date Received: February 11, 2010
Date of Event: January 15, 2010
Report Date: January 15, 2010
Manufacturer: WARSAW ORTHOPEDIC INC.
Product Code: KWQ
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B) (4): THE LOT OF THE SUSPECT DEVICE WAS NOT IDENTIFIED, THEREFORE, THE MANUFACTURER CANNOT DETERMINE THE SUSPECT DEVICE. THE SUSPECT DEVICES IN USE ARE LOT # 0032574W AND # 0049267W. 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 # 812-853T, 510K # K965193 WAS CLEARED IN THE UNITED STATES. MANUFACTURE DATE FOR LOT W08E0313 IS 05/16/2008; MANUFACTURE DATE FOR LOT W08E1547 IS 06/04/2008; MANUFACTURE DATE FOR LOT 0032574W IS 06/05/2009; MANUFACTURE DATE FOR LOT 0049267W IS 08/12/2009. 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 PT UNDERWENT A PLIF AT T12-S1 USING POSTERIOR FIXATION. IT WAS REPORTED THAT ONE OF THE S1 SET SCREWS COULD NOT BE IMPLANTED BECAUSE IT MIGHT HAVE BEEN DAMAGED BY A STABILIZER. NO SET SCREW WAS IMPLANTED AT S1. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LIBERTY POSTERIOR SPINAL SYSTEM	LOCKING SCREW	KWQ	WARSAW ORTHOPEDIC INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNK			ROD\| BONE SCREW\| IMPLANT:\| IMPLANT: