FDA Adverse Event Injury Summary report: N

CD HORIZON SPINAL SYSTEM

MDR report key: 1696104 · Received May 20, 2010

Report

Report Number: 1030489-2010-00663
Event Type: Injury
Date Received: May 20, 2010
Report Date: April 20, 2010
Manufacturer: WARSAW ORTHOPEDIC INC.
Product Code: KWP
PMA / PMN Number: NA
Adverse Event: Yes
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 MFR CANNOT DETERMINE THE SUSPECT DEVICE. THE LOTS THAT WERE USED ARE LOT# W08G3910 AND W08H1568. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG # 7540000, 510K # K031655 WAS CLEARED IN THE UNITED STATES. MANUFACTURE DATE FOR LOT W08G3910 IS 08/15/2008; MANUFACTURE DATE FOR LOT W08H1568 IS 08/25/2008. 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A FUSION PROCEDURE AT RIGHT L1-5 DUE TO RHEUMATOID USING POSTERIOR FIXATION AT L1-L5. THE L5 SET SCREW BACKED OUT AND L5 PEDICLE SCREW SUBSEQUENTLY BACKED OUT POST OP. THE PT DEVELOPED A MILD NEUROLOGICAL SYMPTOM DUE TO THE SCREW BACK OUT. THE REVISION SURGERY WAS PERFORMED AT UNK TIME POST OP TO REMOVE AND REPLACE THE L5 IMPLANTS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CD HORIZON SPINAL SYSTEM	SET SCREW	KWP	WARSAW ORTHOPEDIC INC.	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	59 YR		Required Intervention	ROD:\| EXPLANT:\| IMPLANT:\| IMPLANT:\| PEDICLE SCREWS:\| SET SCREWS:\| IMPLANT: