FDA Adverse Event Malfunction Summary report: N

VERTE-STACK® SPINAL SYSTEM

MDR report key: 2822916 · Received November 7, 2012

Report

Report Number: 1030489-2012-02011
Event Type: Malfunction
Date Received: November 7, 2012
Date of Event: October 29, 2012
Report Date: December 17, 2012
Manufacturer: MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
Product Code: MQP
PMA / PMN Number: K052261
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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.

Additional Manufacturer Narrative · 1

(B)(4). 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.

Additional Manufacturer Narrative · 1

(B)(4): ANALYSIS OF THE RETURNED DEVICE SHOWS THAT VISUAL AND OPTICAL EXAMINATION CONFIRMS THE IMPLANT IS BROKEN, WITH MULTIPLE CRACKS. PLASTIC DEFORMATION AT THE INSERTER INTERFACE AND WITNESS MARKS ON THE ADJACENT FACE OF THE ANTERIOR FACE IS CONSISTENT WITH OVERLOAD. THE ABOVE OBSERVATIONS ARE CONSISTENT WITH BRITTLE OVERLOAD.

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 A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. DURING IMPLANTATION OF A CAGE, THE CAGE FRACTURED AND BROKE IN HALF. THE BROKEN CAGE WAS REMOVED AND A NEW CAGE WAS USED TO COMPLETE THE PROCEDURE. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	VERTE-STACK® SPINAL SYSTEM	SPINAL VERTEBRAL BODY REPLACEMENT DEVICE	MQP	MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH		NV64

Patients

Seq	Age	Sex	Outcome	Treatment
1	00055 YR