FDA Adverse Event Injury Summary report: N

2520274-2013-10508

MDR report key: 2973832 · Received February 19, 2013

Report

Report Number: 2520274-2013-10508
Event Type: Injury
Date Received: February 19, 2013
Report Date: May 28, 2006
Manufacturer: SYNTHES USA
Product Code: MNI
Adverse Event: 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. WITHOUT A PART NUMBER OR LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

Description of Event or Problem · 1

PT PARTICIPATED IN A MULTI-CENTER STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE (DDD) BETWEEN L2 AND S1. PREOPERATIVE DIAGNOSIS WAS DISC FAILURE OR PROLAPSE AND SPONDYLOLISTHESIS, DEGENERATIVE. PT WAS IMPLANTED WITH A TRANSFORAMINAL POSTERIOR LUMBAR INTERBODY FUSION(TPLIF) SPACER AT LEVELS L4L5SIZE, WITH PEDICLE SCREWS AT L4 AND L5. PT WAS ALSO IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. PT HAD BEEN EXPERIENCING PAIN FOR 30 MONTHS. SURGERY DATE WAS (B)(6) 2006, AND POSTOPERATIVELY PT EXPERIENCED DURAL TEAR, REQUIRING DURAL REPAIR WITH ISSUE PLACEMENT. THIS IS REPORT 1 OF 14 FOR THIS EVENT. THIS REPORT IS ON THE CURVED ROD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
72883			MNI	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention