BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI COLLAR WITH GROOVES

    MDR report key: 3063728 · Received April 17, 2013

    Report

    Report Number
    2530088-2013-10438
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Date of Event
    November 30, 2012
    Report Date
    November 30, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MNH
    PMA / PMN Number
    K091689
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE PRODUCT DEVELOPMENT EVENT EVALUATION REVEALED THAT THE COLLAR (498.011 LOT 6972171) WAS FOUND TO BE BENT AND BROKEN BUT NOT SEPARATED INTO MULTIPLE PIECES. RADIAL SCRATCHES IN THE TOP SURFACE OF THE COLLAR INDICATE CONTACT WITH THE MATING NUT. HOWEVER, THE MARKS ARE INCOMPLETE IN THE AREAS OF THE BENT AND BREAK. THIS MAY INDICATE BENDING OF THE COLLAR PRIOR TO CONTACT WITH THE NUT. MARKS ON THE TAB OF THE COLLAR INDICATE CONTACT WITH THE MATING ROD. RADIAL SCRATCHES ON THE OUTER SURFACE ARE FOUND ONLY ON ONE SIDE OF THE BROKEN COLLAR. THIS PARTIAL SCRATCH MAY INDICATE OFF AXIS ENGAGEMENT OF THE SCREWDRIVER AND OR BENDING OF THE COLLAR BEFORE OR DURING TIGHTENING. THE USS SYSTEM HAS BEEN EXTENSIVELY REVIEWED BASED ON PREVIOUS SIMILAR COMPLAINTS AND THE DESIGN OF THE COLLAR, NUT, ROD, AND SCREW HAS BEEN REVIEWED AND DETERMINED TO BE APPROPRIATE FOR ITS INTENDED USE. BASED ON THE DESCRIPTION IT IS UNCLEAR IF ACTIONS IN ADDITION TO TIGHTENING OF THE NUT CAUSED THE COLLAR TO BREAK. SIGNIFICANT LATERAL FORCES COMBINED WITH IMPACTION, OVER TORQUE ON THE NUT ARE POSSIBLE. BECAUSE THE CAUSE OF THE DEVICE FAILURE IS UNKNOWN, IT IS CONCLUDED THAT THIS COMPLAINT IS INDETERMINATE. THE MANUFACTURING EVALUATION SHOWED THAT THE COLLAR IS ELONGATED, ONE SIDE IS BROKEN AT L2 FEATURE WHERE THE GROOVES ARE, AND THE OTHER SIDE IS CRACKED AND DAMAGED ON TOP OF THE GROOVES. THIS DAMAGE IS NOT MANUFACTURE RELATED.

    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. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THORACIC SPINE TRAUMA DISLOCATION/FRACTURE AT T12, THE SURGEON WAS IMPLANTING ROD AND SCREW FIXATION FROM T2-L3 ON PATIENT WITH TRAUMA FRACTURE/DISLOCATION AT T12 SUSTAINED WHEN SHE WAS HIT BY A CAR, AND WHEN THE SURGEON WAS TIGHTENING THE RIGHT T2 SCREW TO THE ROD, THE USS COLLAR CRACKED AND WOULD NOT HOLD TO THE ROD. THE SURGEON REMOVED THE CRACKED COLLAR, AND REPLACED IT WITH ANOTHER USS COLLAR, AND COMPLETED THE PROCEDURE WITH NO FURTHER PROBLEM. PATIENT IS REPORTEDLY RECOVERING FROM THORACIC SPINE SURGERY, WITH NO ADVERSE EFFECTS FROM THE CRACKED COLLAR. OTHER INJURIES SUSTAINED ARE STILL BEING TREATED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164505 TI COLLAR WITH GROOVES MNH SYNTHES BRANDYWINE 6972171

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR