FDA Adverse Event Injury Summary report: N

2520274-2013-10525

MDR report key: 2980392 · Received February 22, 2013

Report

Report Number: 2520274-2013-10525
Event Type: Injury
Date Received: February 22, 2013
Report Date: April 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

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. 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.

Description of Event or Problem · 1

THE PATIENT PARTICIPATED IN (B)(4) STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. THE PATIENT WAS IMPLANTED WITH A TRANSFORMATIVE POSTERIOR LUMBER INTERBODY FUSION (TPLIF) SPACER AT LEVELS L4 AND L5, AND PEDICLE SCREWS AT L3 AND L4. THE PATIENT WAS ALSO IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. POSTOPERATIVELY, THE PATIENT EXPERIENCED A DURAL TEAR, REQUIRING REPAIR WITH SILK STICK AND TISSUE GLUE. THIS COMPLAINT IS ON THE LOCKING CAP AT L3. THIS IS REPORT 6 OF 14 FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
77594			MNI	SYNTHES (USA)

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention