BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ANGLED AWL

    MDR report key: 5172019 · Received October 24, 2015

    Report

    Report Number
    2520274-2015-16779
    Event Type
    Malfunction
    Date Received
    October 24, 2015
    Date of Event
    October 8, 2015
    Report Date
    October 8, 2015
    Manufacturer
    SYNTHES (USA)
    Product Code
    OVE
    PMA / PMN Number
    PK112459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    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. 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

    IT WAS REPORTED THAT DURING A PROCEDURE TO PLACE A ZERO P DEVICE AT LEVEL C3/4 ON (B)(6) 2015, WHILE THE SURGEON WAS USING A MALLET ON A 2.0MM ANGLED AWL, THE GREEN HANDLE OF THE AWL CAME OFF. THERE WERE NO FRAGMENTS GENERATED. THERE WAS ANOTHER DEVICE WAS IMMEDIATELY AVAILABLE. THERE WAS NO SURGICAL DELAY OR PATIENT HARM REPORTED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT INITIALLY UNDERWENT AN ANTERIOR CERVICAL DISCECTOMY FUSION WITH ALLOGRAFT BONE AND A DEPUY SPINE PRODUCT AT LEVELS C4/C5 AND C5/ C6. ON AN UNKNOWN DATE, PATIENT WAS FOUND TO HAVE ADJACENT LEVEL DISEASE AT LEVEL C3/4. PATIENT RETURNED TO THE OPERATING ROOM FOR THE ZERO P PLACEMENT AT C3/4 LEVEL ON (B)(6) 2015. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703831 2.0MM ANGLED AWL INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL OVE SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR