BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI VECTRA(TM) PLATE 2 LEVEL/30MM

    MDR report key: 2993683 · Received March 7, 2013

    Report

    Report Number
    8030965-2013-00777
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KWQ
    PMA / PMN Number
    K050451
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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

    ON (B)(6) 2013, SURGEON WAS PERFORMING A TWO LEVEL ACDF PROCEDURE IN WHICH SURGEON IMPLANTED A VECTRA PLATE AND 6 SCREWS AT THE C4-C6 LEVEL. SURGEON WAS UNEASY WITH THE PLACEMENT OF THE LAST VARIABLE ANGLE SCREW AT THE C6 LEVEL. SURGEON REMOVED AND RE-IMPLANTED THE SAME SCREW. DURING THE RE-IMPLANTING OF THE SCREW, A SMALL PIECE OF THE RETAINING CLIP BROKE OFF. THE LOCKING MECHANISM ON THE PLATE WOULD NOT CLICK OVER THE SCREW. THE SMALL PIECE OF THE BROKEN CLIP WAS REMOVED FROM PATIENT. SURGEON REMOVED SCREW AND LEFT THE PLATE IN PATIENT WITH FIVE SCREWS. SURGEON IS NOT PLANNING A REVISION. AN ADDITIONAL 20 MINUTES WAS ADDED TO THE PROCEDURE. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98327 TI VECTRA(TM) PLATE 2 LEVEL/30MM KWQ SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention