FDA Adverse Event Malfunction Summary report: N

COLORADO SPINAL SYSTEM

MDR report key: 6032981 · Received October 17, 2016

Report

Report Number: 1030489-2016-02907
Event Type: Malfunction
Date Received: October 17, 2016
Date of Event: September 20, 2016
Report Date: November 16, 2016
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

PRODUCT ANALYSIS :VISUALLY CONFIRMED APPROXIMATELY ~15MM OF IMPLANT PROXIMAL TIP HAS BEEN BROKEN OFF. OPTICAL EXAMINATION OF THE FRACTURE SURFACE IDENTIFIED A FAIRLY FLAT FRACTURE SURFACE AND CIRCULAR MATERIAL DISPLACEMENT. THE ABOVE FINDINGS ARE CONSISTENT WITH TORSIONAL OVERLOAD.

Additional Manufacturer Narrative · 1

THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 8630645, 510K# K991031 WAS CLEARED IN THE UNITED STATES. PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE R EPORTED EVENT.

Additional Manufacturer Narrative · 1

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 SPINAL FUSION SURGERY AT L4/5 LEVEL, FOR THE TREATMENT OF SPONDYLOLISTHESIS. DURING SURGERY, WHILE IMPLANTING THE SCREW, IT BROKE AND WAS EXPLANTED. NO FRAGMENT OF THE PRODUCTS REMAINED INSIDE THE PATIENT. THERE WAS A DELAY OF LESS THAN 60 MINUTES IN OVERALL PROCEDURE TIME. NO PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
685352	COLORADO SPINAL SYSTEM	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	KWP	WARSAW ORTHOPEDICS	NA	0372040W

Patients

Seq	Age	Sex	Outcome	Treatment
1