2520274-2013-01466

Report

Report Number: 2520274-2013-01466
Event Type: Injury
Date Received: March 13, 2013
Date of Event: February 11, 2013
Report Date: February 15, 2013
Manufacturer: SYNTHES USA
Product Code: NKB
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. INFORMATION FROM RECEIVED MAUDE REPORT.

Additional Manufacturer Narrative · 1

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 WAS IMPLANTED ON AN UNKNOWN DATE WITH MATRIX SYSTEM FROM L4-S1 FOR POSTERIOR LUMBAR FUSION. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2013 TO EXTEND PREVIOUS FUSION TO L3-L4 DUE TO DEGENERATIVE DISC DISEASE. DURING THE REVISION SURGERY, THE SURGEON DISCOVERED THE RIGHT SIDE ROD WAS BROKEN, AND THE L5 PEDICLE WAS FRACTURED. SURGEON REMOVED TWO RODS, ONE PEDICLE SCREW, AND SIX LOCKING CAPS. PATIENT WAS REVISED WITH TWO LONGER RODS, TWO NEW SCREWS, AND EIGHT CAPS. A SCREW WAS NOT REPLACED IN L5 FRACTURED PEDICLE. THIS REPORT IS FOR AN UNKNOWN MATRIX POLYAXIAL HEAD. THIS IS 18 OF 20 REPORTS FOR THIS EVENT.

Description of Event or Problem · 1

SYNTHES (B)(4) RECEIVED VOLUNTARY MAUDE EVENT REPORT: (B)(4) FROM THE FDA: REPORTEDLY SYNTHES CURVED SPINAL RODS REMOVED FROM PATIENT 11 MONTHS AFTER IMPLANTATION. ONE ROD WAS COMPLETELY SEVERED. THE OTHER WAS REMOVED PROPHYLACTICALLY. PATIENT DEVELOPED A MASSIVE INFECTION 11 DAYS POST-OP FROM THE ORIGINAL INSERTION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
105050			NKB	SYNTHES USA

Patients

Seq	Age	Sex	Outcome	Treatment
1	67 YR		Required Intervention