FDA Adverse Event Injury Summary report: N

CD HORIZON SPINAL SYSTEM

MDR report key: 1895336 · Received November 2, 2010

Report

Report Number: 1030489-2010-01420
Event Type: Injury
Date Received: November 2, 2010
Date of Event: September 10, 2010
Report Date: October 14, 2010
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

(B)(4). NEITHER DEVICE NOR FILM OR APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MFR FOR EVAL. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT.

Additional Manufacturer Narrative · 1

MACROSCOPIC AND OPTICAL EXAMINATION IDENTIFIES ASYMMETRICAL AND EXCESSIVE GAP BETWEEN THE SET SCREW AND THE CROSSLINK ARM, WITH PLASTIC DEFORMATION NOTED. THIS SUGGESTS POSSIBLE MISALIGNMENT OF THE DRIVER DURING ATTEMPTED REMOVAL, CREATING A BENDING MOMENT AND SUBSEQUENT BINDING AND/OR DEFORMATION OF THE THREADS, AND DISALLOWING PROPER REMOVAL OF THE SCREW.

Additional Manufacturer Narrative · 1

THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8115545, 510K # (B)(6) WAS CLEARED IN THE UNITED STATES. DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 REVISION SURGERY TO EXPLANT CROSSLINK DUE TO POST OP PAIN. NO PT COMPLICATIONS WERE REPORTED DURING AND AFTER THE REVISION PROCEDURE.

Description of Event or Problem · 1

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CD HORIZON SPINAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	WARSAW ORTHOPEDIC INC.	ASKU	0024620W

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	IMPLANT:\| POSTERIOR FIXATION CONSTRUCT