BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI LOCKING SCREW

    MDR report key: 4240982 · Received November 10, 2014

    Report

    Report Number
    2520274-2014-14580
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    October 15, 2014
    Report Date
    October 15, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWP
    PMA / PMN Number
    PK142460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES: MNH, MNI. 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. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THE SERVICE & REPAIR DEPARTMENT DOCUMENTED A REPORT FROM THE SALES CONSULTANT THAT THE 2NM TORQUE LIMITING HANDLE WITH QUICK COUPLING TORQUE HANDLE WOULD NOT RELEASE AT THE SPECIFIED TORQUE AND A TI LOCKING SCREW WAS STRIPPED DURING C3-C7 POSTERIOR CERVICAL FUSION SURGERY ON (B)(6), 2014. AN UNKNOWN SCREWDRIVER INTERACTED WITH THE LOCKING SCREW BASED UPON TECHNIQUE GUIDE. FRAGMENTS WERE REMOVED EASILY, WITHOUT ADDITIONAL INTERVENTION. THERE WAS NO DELAY IN SURGERY. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PATIENT IS REPORTEDLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722517 TI LOCKING SCREW APPLIANCE,FIXATION,SPINAL INTERLAMINAL KWP SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR