FDA Adverse Event Injury Summary report: N

CD HORIZON SPINAL SYSTEM

MDR report key: 1680664 · Received May 7, 2010

Report

Report Number: 1030489-2010-00613
Event Type: Injury
Date Received: May 7, 2010
Date of Event: April 9, 2010
Report Date: April 9, 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): THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, A LIKE DEVICE CATALOG #8699120, 510 # K K981676 WAS CLEARED IN THE UNITED STATES. NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS 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 PT UNDERWENT A SPINAL PROCEDURE TO IMPLANT POSTERIOR FIXATION AT L2-S1. THE FIXATION ROD BROKE AT L5-S1 POST OP. THE REVISION SURGERY WAS PERFORMED APPROX A YEAR POST OP TO REPLACE THE ROD AND THE SCREW, THE FIXATION LEVEL WAS EXTENDED TO THE ILIAC. IT WAS CONFIRMED AT THE REVISION SURGERY THAT THE FUSION WAS COMPLETE AT L2-L4, BUT L5-S1 DID NOT FUSE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CD HORIZON SPINAL SYSTEM	ROD	KWP	WARSAW ORTHOPEDIC INC.	NA	W08J2920

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	IMPLANT DATE:\| EXPLANT DATE:\| BONE SCREW