FDA Adverse Event Injury Summary report: N

2520274-2013-10067

MDR report key: 2960759 · Received February 11, 2013

Report

Report Number: 2520274-2013-10067
Event Type: Injury
Date Received: February 11, 2013
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 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

PATIENT PARTICIPATED IN A MULTI-CENTER STUDY OF TREATMENT FOR 1 OR 2 LEVEL DEGENERATIVE DISC DISEASE BETWEEN L2 AND S1. POSTOPERATIVE DIAGNOSIS WAS DISC FAILURE OR PROLAPSE. PATIENT WAS IMPLANTED WITH A TPLIF SPACER AT LEVELS L5S1 SIZE WITH PEDICLE SCREWS AT L5 AND S1. PATIENT WAS ALSO IMPLANTED WITH CLICK-X FOR SUPPLEMENTAL FIXATION. PATIENT HAD BEEN EXPERIENCING PAIN FOR 11 MONTHS. SURGERY DATE WAS (B)(6) 2005, AND POSTOPERATIVELY PATIENT EXPERIENCED LEFT ANKLE PAIN LEFT LEG AND FOOT SWELLING, REQUIRING EPIDURAL STEROID INJECTION AT L5-S1. THIS COMPLAINT IS ON THE LOCKING CAP AT L5. THIS IS REPORT 9 OF 14 FOR THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
59956			MNI	SYNTHES (USA)

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention