FDA Adverse Event Injury Summary report: N

CD HORIZON SPINAL SYSTEM

MDR report key: 10199073 · Received June 26, 2020

Report

Report Number: 1030489-2020-00730
Event Type: Injury
Date Received: June 26, 2020
Report Date: June 26, 2020
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 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 UNDERWENT POSTERIOR FIXATION SURGERY AT T2 TO IL DUE TO DEGENERATIVE KYPHOSCOLIOSIS. POST-OP, THE SET SCREW ON THE OPEN SIDE OF RC CONNECTOR, WHICH WAS USED AT THE FIRST TIME OF POSTERIOR FIXATION, BACKED OUT/DEVIATED IN A YEAR. THE SURGEON NOTICED THIS EVENT WHEN THE PATIENT VISITED THE HOSPITAL FOR FOLLOW UP. PATIENT UNDERWENT REVISION SURGERY AS A RESULT OF THIS EVENT TO RE-INSERT THE SET SCREW AND REINFORCEMENT WAS DONE WITH FOUR RODS. THERE WERE NO PATIENT COMPLICATIONS IN THE REVISION SURGERY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
663850	CD HORIZON SPINAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	WARSAW ORTHOPEDICS	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention