BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMIDFACE SCREWDRIVER BLD SELF-RETAINING F/90° SCREWDRIVER

    MDR report key: 3810264 · Received May 14, 2014

    Report

    Report Number
    2520274-2014-11458
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. LOT NUMBER AND MANUFACTURING LOCATION IS UNKNOWN AND CANNOT BE VERIFIED, THEREFORE A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE COMPLETED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE SCREWDRIVER WAS UNABLE TO RETAIN SCREWS, SO IT TOOK MORE TIME THAN USUAL TO COMPLETE THE OPERATION. IN ADDITION, THE SHAFT ATTACHED TO THE DRILL BIT WAS OVERHEATING DURING THE DRILLING WITH CORE (STRYKER) AND THE PATIENT SUFFERED A MILD BURN ON THE SUB MUCOSAL TISSUE ON THE CHEEK. THERE WAS MINIMAL SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288452 MATRIXMIDFACE SCREWDRIVER BLD SELF-RETAINING F/90° SCREWDRIVER SCREWDRIVERS HXX

    Patients

    Seq Age Sex Outcome Treatment
    1