FDA Adverse Event Malfunction Summary report: N

6.0MM TI PANGEA POLYAXIAL

MDR report key: 2986409 · Received February 26, 2013

Report

Report Number: 2530088-2013-10144
Event Type: Malfunction
Date Received: February 26, 2013
Report Date: March 4, 2011
Manufacturer: SYNTHES (USA) BRANDYWINE
Product Code: NKB
PMA / PMN Number: K103287
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SZ
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADD'L INFO RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT EVAL REVEALED THAT THE BODY WAS NOT ATTACHED TO THE SCREW, COLLET AND SLEEVE. BODY HAS SCRATCHES AND NICKS ON OD AND ID WITH ASSEMBLE WITNESS LINES FROM SLEEVE. THE COLLET HAS SCORE LINE, IMPRINTS AND GALLING FROM SCREW HEAD IN SPHERICAL ID. ALL DESCRIBED WOULD BE POST MFG. THE RETURNED IMPLANT COULD NOT BE USED TO FULLY REPLICATE THE EVENT IN THE DISASSEMBLED CONDITION. THERE IS NO APPARENT INDICATION OF A DESIGN-RELATED ISSUE. IT IS CONCLUDED THAT WITH UNOBTAINABLE FEATURES, THIS COMPLAINT IS INDETERMINATE.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PROCEDURE, THE HEAD OF THE 6.0MM TI PANGEA POLYAXIAL SCREW DISMANTLED INTRA-OP. AFTER INSERTING THE SCREW, DR (B)(6) TRIED TO MOBILIZE THE HEAD. THE HEAD DISMANTLED IMMEDIATELY. THE SCREW HAD TO BE REMOVED AND A NEW SCREW HAD TO BE INSERTED. THE PRODUCT OCCURRENCE NOT RELEVANT TO THE HEALTH OF THE PT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
81220	6.0MM TI PANGEA POLYAXIAL		NKB	SYNTHES (USA) BRANDYWINE		6250213

Patients

Seq	Age	Sex	Outcome	Treatment
1