BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREW

    MDR report key: 2231319 · Received July 26, 2011

    Report

    Report Number
    2520274-2011-00523
    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
    K071667
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    POSSIBLE LOT NUMBERS FOR THIS COMPLAINT: 04.613.514: 4.0 MM TI CERVICAL SELF-RETAINING SCREW, 04.613.564: 4.5 MM TI CERVICAL SELF RETAINING SCREW. 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. IT WAS REPORTED THAT PATIENT WAS IMPLANTED WITH SEVEN (7) SCREWS USED IN PROCEDURE WITH PART NUMBER LISTED AS (B)(4). AN ADDITIONAL SCREW, ALSO PART OF THE PROCEDURE, HAS A PART NUMBER LISTED AS (B)(4). THE 510K NUMBER FOR ALL OF THE SCREWS WITH EACH ASSOCIATED PART NUMBER IS K071667.

    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 (04.613.248). 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 FOUR OF FIVE REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK - SCREW SCREW KWQ SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR PLATE| SCREWS