FDA Adverse Event Malfunction Summary report: N

2520274-2013-10935

MDR report key: 3003323 · Received February 28, 2013

Report

Report Number: 2520274-2013-10935
Event Type: Malfunction
Date Received: February 28, 2013
Date of Event: February 20, 2002
Report Date: February 20, 2002
Manufacturer: SYNTHES USA
Product Code: MNI
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

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. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED.

Description of Event or Problem · 1

PT PARTICIPATED IN A (B)(6) STUDY OF 1 OR 2 CONSECUTIVE LEVEL FUSIONS BETWEEN L2 AND S1 USING EITHER AUTOGRAFT ALONE OR DBX DEMINERALIZED BONE MATRIX PUTTY WITH AUTOGRAFT. PT WAS IMPLANTED WITH CLICK'X FOR SUPPLEMENTAL FIXATION. POSTOPERATIVELY, PT EXPERIENCED PAIN REQUIRING REFERRAL TO A PAIN CLINIC. THIS IS REPORT 7 OF 14 FOR THIS EVENT. THIS REPORT IS ON THE LOCKING CAP.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
86938			MNI	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR