FDA Adverse Event Malfunction Summary report: N

SOVEREIGN SPINAL SYSTEM

MDR report key: 1981938 · Received February 8, 2011

Report

Report Number: 1030489-2011-00102
Event Type: Malfunction
Date Received: February 8, 2011
Date of Event: January 12, 2011
Report Date: January 12, 2011
Manufacturer: MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH
Product Code: MAX
PMA / PMN Number: K091813
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). NEITHER DEVICE NOR FILM OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. WE ARE UNABLE TO DETERMINE THE CAUSE OF THE EVENT. DEVICE HISTORY RECORDS WERE REVIEWED. NO DOCUMENTATION WAS FOUND THAT WOULD INDICATE A NON-CONFORMANCE TO SPECIFICATIONS.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A SPINAL PROCEDURE TO IMPLANT THE INTERBODY CAGE AT L4/L5, THE CAGE CRACKED AT THE SCREW IN THE INFERIOR RIGHT SIDE DURING SCREW TIGHTENING. THE COVER CAGE WOULD NOT BE IMPLANTED BECAUSE OF THAT. THE RIGHT INFERIOR SCREW WAS REMOVED AND THEN THE COVER PLATE COULD BE IMPLANTED. ONE SCREW AT THE SUPERIOR SIDE AND ONE SCREW AT THE LEFT INFERIOR HOLE WERE IMPLANTED. THE COVER PLATE LOCKED IN PLACE ON BOTH SIDES. NO PATIENT COMPLICATIONS WERE REPORTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PEEK CAGE IMPLANT CRACKED DURING SCREW TIGHTENING WHICH CAUSED THE COVER PLATE NOT TO GO ON. THE SCREW AT WHERE THE PLATE CRACKED WAS REMOVED AND THE COVER PLATE WORKED. NO PATIENT COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SOVEREIGN SPINAL SYSTEM	INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR	MAX	MEDTRONIC SOFAMOR DANEK DEGGENDORF GMBH	NA	202539613

Patients

Seq	Age	Sex	Outcome	Treatment
1	00041 YR			FIXATION SCREW