FDA Adverse Event Injury Summary report: N

CD HORIZON SPINAL SYSTEM

MDR report key: 8098504 · Received November 22, 2018

Report

Report Number: 1030489-2018-01524
Event Type: Injury
Date Received: November 22, 2018
Report Date: November 22, 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

THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: (PRODUCT ID: 1476106500, LOT: 0244459W) AND (PRODUCT ID: 1476106500, LOT: 0299637W). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. G5: THIS PRODUCT IS NOT APPROVED FOR USE IN THE US, HOWEVER A LIKE DEVICE WITH PART# 1476006150, 510K# K121680 AND UPN 00643169147010 HAS BEEN CLEARED FOR US. H6: NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WAS PRE-OPERATIVELY DIAGNOSED WITH SPINAL CANAL STENOSIS AND UNDERWENT OBLIQUE LUMBAR INTERBODY FUSION. POST-OP,THE ROD ON THE RIGHT SIDE WAS BROKEN. ROD REPLACEMENT WAS PERFORMED ONLY ON THE RIGHT SIDE, AND INSTALLED TWO PROLOCK, ALSO PERFORMED BONE GRAFTING WITH ARROW GRAFT, THEN THE OPERATION WAS COMPLETED. THE OLIF OF 3 INTERVERTEBRAL DISC WAS PERFORMED ON L2-5 AND POSTERIOR FIXATION TO T9-S WAS PERFORMED WITH V4. PATIENT COMPLICATIONS REPORTED TO BE UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
938589	CD HORIZON SPINAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	WARSAW ORTHOPEDICS	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Required Intervention