BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI VECTRA(TM) PLATE 3 LEVEL/48MM

    MDR report key: 2231321 · Received July 26, 2011

    Report

    Report Number
    2520274-2011-00521
    Event Type
    Malfunction
    Date Received
    July 26, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 28, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    KWQ
    PMA / PMN Number
    K050451
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    THE BRAND NAME OF THE DEVICE WAS CORRECTED FROM UNK-PLATE TO TI VECTRA(TM) PLATE 3 LEVEL/48MM. CATALOG #: THE CATALOG NAME WAS REPORTED AS UNK-PLATE ON THE INITIAL MEDWATCH REPORT. THE CATALOG # WAS CORRECTED FROM UNK-PLATE TO 04.613.248. THE CATALOG # WAS REPORTED ON THE FIRST FOLLOW-UP REPORT BUT WAS NOT CLARIFIED AS A CORRECTION.

    Description of Event or Problem · 1

    DURING AN ACDF PROCEDURE AT C4-CY ON (B)(6) 2011, PT WAS IMPLANTED WITH A 3-LEVEL VECTRA PLATE (B)(4). X-RAYS TAKEN 6 WEEKS POST-OPERATIVE INDICATE "THE C7 SCREWS PROJECT ANTERIOR TO THE PLATE AND MAY HAVE RETRACTED AND LUCENCY OF THE C6 SCREWS SUGGESTIVE OF MOVEMENT/LOOSENING." PT HAS NOT BEEN REVISED AND SCREWS CURRENTLY REMAIN IN THE PT. REPORTEDLY, THE SCREWS THAT WERE PLACED WERE P/N 04.613.514, P/N 04.613.564. WHICH SCREWS BACKED OUT AND WHICH ONES ARE LOOSE WERE NOT PROVIDED ON COMPLETED QUESTIONNAIRE RECEIVED. THIS IS TWO OF FIVE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI VECTRA(TM) PLATE 3 LEVEL/48MM PLATE KWQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR SCREWS