FDA Adverse Event Injury Summary report: N

SYNFIX-LR 26MM DEPTH/32MM

MDR report key: 2994011 · Received February 27, 2013

Report

Report Number: 8030965-2013-10250
Event Type: Injury
Date Received: February 27, 2013
Date of Event: March 11, 2011
Report Date: March 11, 2011
Manufacturer: SYNTHES GMBH
Product Code: MAX
PMA / PMN Number: K072253
Adverse Event: Yes
Report Source: Manufacturer report
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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RECEIVED FOR EVALUATION.

Description of Event or Problem · 1

UPON IMPACTION DURING AN ANTERIOR LUMBAR INTERBODY FUSION (ALIF) PROCEDURE AT L4-L5, THE TAB ON THE IMPLANT HOLDER BROKE OFF INTO THE SYNFIX-LR. THE GRAFT WAS REMOVED AND REPLACED WITH ANOTHER GRAFT. AN ADDITIONAL 15 MINUTES WAS ADDED TO THE PROCEDURE. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
84150	SYNFIX-LR 26MM DEPTH/32MM		MAX	SYNTHES GMBH		2477233

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention