BEUDAMED
    FDA Adverse Event Other Summary report: N

    CANNULATED SCREW 4.0

    MDR report key: 2640497 · Received June 25, 2012

    Report

    Report Number
    8043862-2012-00013
    Event Type
    Other
    Date Received
    June 25, 2012
    Date of Event
    July 18, 2011
    Report Date
    June 21, 2012
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HWC
    PMA / PMN Number
    K080101
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT HAS RECEIVED A BONE PLATE FROM ANOTHER MANUFACTURER AND A CANNULATED SCREW FROM AAP (B)(4). THE BONE PLATE BROKE DUE TO A NON-UNION AND WAS REMOVED. ALSO THE CANNULATED SCREW WAS REMOVED BUT DID NOT FAIL. THE REMOVAL OF THE SCREW WAS ONLY BECAUSE OF THE SECOND APPLICATION OF ANOTHER IMPLANT.

    Description of Event or Problem · 1

    ALLEGEDLY PLATE WAS REVISED DUE TO A BROKE PLATE. THE PATIENT HAD A NON-UNION. THE AAP CANNULATED SCREW HAS BEEN REMOVED ALSO BUT DID NOT FAIL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CANNULATED SCREW 4.0 BONE SCREW HWC AAP IMPLANTATE AG SCN403022 W002

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention