FDA Adverse Event Malfunction Summary report: N

T2 ALTITUDE¿ EXPANDABLE CORPECTOMY SYSTEM

MDR report key: 2832373 · Received November 14, 2012

Report

Report Number: 1030489-2012-02197
Event Type: Malfunction
Date Received: November 14, 2012
Date of Event: November 9, 2012
Report Date: December 17, 2012
Manufacturer: MEDTRONIC SOFAMOR DANEK USA, INC
Product Code: MQP
PMA / PMN Number: K100976
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
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

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

Additional Manufacturer Narrative · 1

(B)(6). (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

ADDITIONAL INFORMATION: ANALYSIS OF THE RETURNED DEVICE SHOWS THAT THE BREAKAGE OF BOTH INSTRUMENTS IS CONSISTENT WITH OVERLOAD. AS THE INSTRUMENTS COULD BE OVERLOADED AT DIFFERENT STEPS OF THE SURGERY, THE ORIGIN OF THE OVERLOAD CANNOT BE DETERMINED WITH THE PROVIDED INFORMATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SPINAL PROCEDURE. DURING THE PROCEDURE, THE TIPS OF TWO DRIVERS BROKE. THE BROKEN PIECES WERE ABLE TO BE RETRIEVED. NO FURTHER DETAILS ARE KNOWN AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	T2 ALTITUDE¿ EXPANDABLE CORPECTOMY SYSTEM	SPINAL VERTEBRAL BODY REPLACEMENT DEVICE	MQP	MEDTRONIC SOFAMOR DANEK USA, INC	NA	CA12A038

Patients

Seq	Age	Sex	Outcome	Treatment
1	00057 YR