FDA Adverse Event Injury Summary report: N

CD HORIZON® SPINAL SYSTEM

MDR report key: 7471732 · Received April 30, 2018

Report

Report Number: 1030489-2018-00623
Event Type: Injury
Date Received: April 30, 2018
Report Date: December 3, 2018
Manufacturer: WARSAW ORTHOPEDICS
Product Code: KWP
PMA / PMN Number: SEE H10
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS PART IS NOT APPROVED FOR SALE IN US BUT A SIMILAR DEVICE WITH CATALOG# 778116565 , 510K# K090390 AND UDI (B)(4) IS APPROVED FOR SALE IN US. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO MANUFACTURER FOR EVALUATION THEREFORE WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

PRODUCT ANALYSIS RESULT: VISUAL MICROSCOPIC THE CONNECTOR HAS A WEAR MARK INSIDE OF THE ROD SLOT FROM THE ROD MOVING BACK IN FOURTH. THE ROD APPEARS TO HAVE MOVED AND IS ANGLED IN RELATIONSHIP WITH THE CONNECTOR AXIS. THE THREADS DO NOT APPEAR TO BE DAMAGED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT PATIENT UNDERWENT EXTENSION OF FUSION TO TH3 FROM TH8-S2AI. POST-OP, PAIN WAS OBSERVED DUE TO BACKING OUT OF CONNECTOR. VERTEBRAL BODY FRACTURE OCCURRED AT T3 OF THE MOST CRANIAL SIDE, AND HENCE THE FUSION FOR EXTENDING TO C7 WAS PERFORMED. BECAUSE CONNECTORS ON THE BOTH SIDES WERE SHAVED AND THE ROD WAS NOT FIXED, THEY BACKED OUT EASILY. THE PHYSICIAN JUDGED THAT THE ROD CAME OFF BECAUSE THE CONNECTOR MOVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
316731	CD HORIZON® SPINAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	WARSAW ORTHOPEDICS	NA	0451961W

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	ROD