FDA Adverse Event Malfunction Summary report: N

VERTE-STACK® SPINAL SYSTEM

MDR report key: 4150420 · Received October 7, 2014

Report

Report Number: 1030489-2014-03900
Event Type: Malfunction
Date Received: October 7, 2014
Date of Event: September 5, 2014
Report Date: December 1, 2014
Manufacturer: MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
Product Code: MQP
PMA / PMN Number: K062133
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NZ
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. D2: THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 2966050, PRODUCT CODE MQP WAS CLEARED IN THE UNITED STATES. THIS PART IS NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER A LIKE DEVICE CATALOG # 2966050, 510K # K062133 WAS CLEARED IN THE UNITED STATES.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT ONLY ONE SMALL FRAGMENT FROM ONE ASSOCIATED IMPLANT RETURNED FOR ANALYSIS. MICROSCOPIC EXAMINATION OF THE FRAGMENT FRACTURE SURFACE IDENTIFIED BRITTLE FRACTURE AND RIVER LINES CONSISTENT WITH BRITTLE OVERLOAD.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT A DLIF PROCEDURE, DURING THE PROCEDURE THE CAGES BROKE OFF WHILE INSERTING. NO BROKEN PIECES COULD BE SEEN IN THE PATIENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
628892	VERTE-STACK® SPINAL SYSTEM	SPINAL VERTEBRAL BODY REPLACEMENT DEVICE	MQP	MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH	2966050INT	UZ30

Patients

Seq	Age	Sex	Outcome	Treatment
1	00068 YR