FDA Adverse Event Malfunction Summary report: N

TI MATRIXNEURO SCREW SELF-DRILLING 4MM

MDR report key: 2993643 · Received March 7, 2013

Report

Report Number: 1719045-2013-10298
Event Type: Malfunction
Date Received: March 7, 2013
Report Date: November 17, 2011
Manufacturer: SYNTHES (USA)
Product Code: JEY
PMA / PMN Number: K042365
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

ADDITIONAL NARRATIVE: 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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

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.(B)(4)

Description of Event or Problem · 1

SYNTHES (B)(4) REPORTED THAT A NEUROSURGEON HAD SHEARED THE HEADS OFF 3 MATRIX NEURO SCREWS UPON INSERTION. IT IS NOT KNOWN WHETHER THE SCREWS WERE REMOVED AND REPLACED. IT IS UNKNOWN IF THE SCREW WILL BE RETURNED FOR INVESTIGATION. THIS IS REPORT 3 OF 3 FOR THIS EVENT.

Description of Event or Problem · 1

THIS IS REPORT 3 OF 3 FOR THIS COMPLAINT (B)(4)

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
97250	TI MATRIXNEURO SCREW SELF-DRILLING 4MM		JEY	SYNTHES (USA)

Patients

Seq	Age	Sex	Outcome	Treatment
1