FDA Adverse Event Malfunction Summary report: N

MATNEU SCR Ø1.5 SELF-DRILL L5 TAN 1U I/C

MDR report key: 2914617 · Received January 14, 2013

Report

Report Number: 2520274-2013-00317
Event Type: Malfunction
Date Received: January 14, 2013
Date of Event: July 7, 2009
Report Date: July 28, 2009
Manufacturer: SYNTHES
Product Code: JEY
PMA / PMN Number: NON-US
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

Description of Event or Problem · 1

THE (B)(6) REPORTED THAT THE SCREWS BROKE DURING INSERTION. THE PATIENT WAS BEING TREATED FOR CRANIOPLASTY. ONE SCREW BROKE AT THE SCREW TIP DURING INSERTION AND ONE SCREW HEAD BROKE DURING FINAL TIGHTENING. THE BROKEN PARTS REMAIN IN THE PATIENTS BODY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
20436	MATNEU SCR Ø1.5 SELF-DRILL L5 TAN 1U I/C	MATRIXNEURO SELF DRILLING SCREW	JEY	SYNTHES

Patients

Seq	Age	Sex	Outcome	Treatment
1