FDA Adverse Event Malfunction Summary report: N

ZODIAC PEDICLE SCREW SYSTEM

MDR report key: 996946 · Received February 12, 2008

Report

Report Number: 2027467-2008-00001
Event Type: Malfunction
Date Received: February 12, 2008
Date of Event: January 15, 2008
Report Date: February 8, 2008
Manufacturer: ALPHATEC SPINE, INC.
Product Code: MNI
PMA / PMN Number: K033090
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE PARTS WERE RETURNED TO ALPHATEC SPINE INC AND EVALUATED. THE EVALUATION CONFIRMS THAT THE SCREWS WERE BROKEN. BOTH OF THE SCREWS ARE BROKEN IN THE MIDDLE OF THE THREADED PORTION OF THE SCREWS. AN EVALUATION OF THE DEVICE HISTORY RECORD DOES NOT REVEAL ANY QUALITY CONCERNS. REQUESTS HAVE BEEN MADE TO THE SURGEON TO PROVIDE COPIES OF THE X-RAY THAT DETECTED THE BROKEN SCREWS. ALPHATEC SPINE INC HAS YET TO RECEIVE THE X-RAYS. THE COPY OF THE X-RAY WILL ASSIST IN DETERMINING THE ROOT CAUSE OF THE SCREW BREAKAGE. ALPHATEC SPINE WILL REPORT ADDITIONAL FOLLOW-UP INFORMATION WHEN THE X-RAYS ARE OBTAINED FROM THE SURGEON. ALTHOUGH THE REPORTED COMPLAINT WAS CONFIRMED, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE WITHOUT EVALUATING THE X-RAYS FOR THE PLACEMENT OF THE SCREWS. THE ROOT CAUSE WAS NOT IDENTIFIED, THERE IS NOT ENOUGH INFORMATION.

Description of Event or Problem · 1

TWO SACRAL SCREWS BROKE POST OPERATIVELY. THE BROKEN SCREWS WERE DETECTED DURING A FOLLOW UP VISIT ON AN X-RAY. THE DATE WHEN THE SCREWS WERE BROKEN IS UNK. THE PT UNDERWENT A REVISION SURGERY TO REMOVE THE LARGER DIAMETER SCREWS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ZODIAC PEDICLE SCREW SYSTEM	ZODIAC POLYAXIAL SCREW SYSTEM	MNI	ALPHATEC SPINE, INC.	62365-40	610028

Patients

Seq	Age	Sex	Outcome	Treatment
1	83 YR		Required Intervention