FDA Adverse Event Malfunction Summary report: N

CD HORIZON SPINAL SYSTEM

MDR report key: 10231423 · Received July 6, 2020

Report

Report Number: 1030489-2020-00814
Event Type: Malfunction
Date Received: July 6, 2020
Date of Event: June 11, 2020
Report Date: July 6, 2020
Manufacturer: WARSAW ORTHOPEDICS
Product Code: KWP
PMA / PMN Number: SEE H10
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 7045855, 510K # K040962, UDI#: (B)(4). WAS CLEARED IN THE UNITED STATES. 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 ANTERIOR LUMBAR FIXATION AT L2-4 AND REPLACEMENT OF SCREW SURGERY DUE TO BURST FRACTURE. INTRA-OP, ONE SCREW INSERTED AT L2 COULD NOT BE BROKEN OFF AT THE FINAL TIGHTENING. THERE WAS A POSSIBILITY THAT THE SCREW INSERTION ANGLE WAS TILTED FROM THE OUTSIDE TO THE INSIDE TOO MUCH, AND MAYBE THE SCREW DID NOT COME IN FROM DIRECTLY ABOVE WHEN THE SET SCREW WAS TIGHTENED, AND IT WAS SUSPECTED THAT THE SCREW WAS CROSS THREADED AND THE THREAD GOT SCRAPED AND SET SCREW IDLED DURING THE FINAL TIGHTENING. THE SCREW WAS REPLACED WITH ANOTHER ONE AND FINAL TIGHTENING WAS PERFORMED WITHOUT PROBLEMS. THERE WAS A DELAY OF LESS THAN 60 MINS IN OVERALL PROCEDURE TIME. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
700729	CD HORIZON SPINAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	WARSAW ORTHOPEDICS	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1