FDA Adverse Event Malfunction Summary report: N

PEDICSCR PANGEAPOLYAX Ø6 CANN PREASSMBL

MDR report key: 3183020 · Received June 21, 2013

Report

Report Number: 2530088-2013-00955
Event Type: Malfunction
Date Received: June 21, 2013
Date of Event: June 28, 2011
Report Date: July 5, 2011
Manufacturer: SYNTHES BRANDYWINE
Product Code: NKB
PMA / PMN Number: K082572
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: OTHER

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 ADDITIONAL INFORMATION 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 EVALUATION REVEALED THAT THE CONICAL ELEMENTS HAD BEEN PULLED OUT OF THEIR ORIGINAL POSITION. DUE TO PREVIOUSLY RECEIVED MARKET FEEDBACK THE FAILURE OF THIS PHENOMENON HAS ALREADY BEEN IDENTIFIED AND IT HAS BEEN NOTED THAT IN CONNECTION WITH SPIRIT, PANGEA SCREWS MAY SUFFER FROM ABOVE DESCRIBED DAMAGE WHEN HANDLED IN A CERTAIN MANNER. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED TO ADDRESS THIS ISSUE. NEVERTHELESS, WE WOULD LIKE TO POINT OUT THAT WHEN THE PANGEA SCREWS ARE USED WITH SPIRIT, IT IS VITAL TO AVOID PUSHING FORWARD THE HOLDING SLEEVE WHILE INSERTING/ADVANCING THE SCREW INTO THE VERTEBRAE. THE SAME APPLIES WHEN ORIENTATING THE HOLDING SLEEVE.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE ROD COULD NOT BE PLACED BECAUSE THE INNER PART WAS ROTATED.THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
283403	PEDICSCR PANGEAPOLYAX Ø6 CANN PREASSMBL		NKB	SYNTHES BRANDYWINE		6651039

Patients

Seq	Age	Sex	Outcome	Treatment
1