FDA Adverse Event Malfunction Summary report: N

MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD

MDR report key: 2915457 · Received January 10, 2013

Report

Report Number: 3004608878-2013-00006
Event Type: Malfunction
Date Received: January 10, 2013
Report Date: January 10, 2013
Manufacturer: INTEGRA LIFESCIENCES CORPORATION OH/USA
Product Code: HBL
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OH, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

Description of Event or Problem · 1

A 3101 MAYFIELD COMPOSITE HAD MOVEMENT THAT OCCURRED DURING TRIALING - THE EVENT WAS DESCRIBED AS "ONCE THE PERFORATOR WAS APPLIED AND THE TEETH SLID OFF ALLOWING MOVEMENT. THE SURGEON REPORTED THAT THE COMPOSITE MAYFIELD HAD MOVEMENT ONCE HE WENT TO APPLY THE PERFORATOR TO DO A BURR HOLE. HE DOES NOT KNOW WHAT CAUSED THE ADD'L MOVEMENT THAT HE SAID WAS MORE THAN THE CURRENT MAYFIELD SYSTEM BUT, HE WANTED TO VOICE HIS CONCERNS. MY EXPERIENCE WITH THE COMPOSITE MAYFIELD LED ME TO BELIEVE THAT THE POINTY PART OF THE TEETH ON THE TRANSITION MEMBER WERE RESTING ON TOP OF EACH OTHER DURING TIGHTENING. ONCE THERE WAS MOVEMENT THESE TEETH SLID OFF OF EACH OTHER AND WENT TO THE APPROPRIATE SPOT BUT SINCE IT WAS NOT TIGHTENED THIS WAY THERE WAS SOME MOVEMENT OR PLAY THAT WAS NOT THERE WHEN THE SURGEON FIRST APPLIED THE UNIT. HE DID NOT KNOW WHEN THIS HAPPENED OR WHICH PT IS HAPPENED ON."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
16008	MAYFIELD COMPOSITE SERIES BASE UNIT, STANDARD	COMPOSITE SERIES	HBL	INTEGRA LIFESCIENCES CORPORATION OH/USA

Patients

Seq	Age	Sex	Outcome	Treatment
1