BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AAP CORTICAL STANDARD SCREW

    MDR report key: 4213133 · Received September 4, 2014

    Report

    Report Number
    8043862-2014-00010
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    April 1, 2014
    Report Date
    September 4, 2014
    Manufacturer
    AAP IMPLANTATE AG
    Product Code
    HWC
    PMA / PMN Number
    K072411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAVE RECEIVED A COUPLE OF COMPLAINT REPORTS WITH AN EMAIL FROM OUR DISTRIBUTOR (B)(4) 2014. TO GET MORE INFORMATION WE SENT A RESPONSE WITH SOME QUESTIONS AND THE REMINDER THAT SUCH COMPLAINTS MUST BE REPORTED EARLIER BECAUSE (B)(4) AS THE MANUFACTURER HAS TO REPORT WITHIN 30 DAYS. IN THIS CASE WE ONLY HAVE RECEIVED THE INFORMATION THAT SOMETHING HAPPENED WITH SOME OF OUR SCREWS. EITHER 2 OR 3. WE HAVE RECEIVED THE INFORMATION THAT IT WILL NOT BE POSSIBLE FOR OUR DISTRIBUTOR TO GET MORE INFORMATION.

    Description of Event or Problem · 1

    2 OR 3 SCREWS BROKE DURING A FINGER FRACTURE SURGERY. ONE OF THE SCREWS ACTUALLY STAYED IN THE PATIENT (HALF OF THE SCREW).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542522 AAP CORTICAL STANDARD SCREW BONE SCREW HWC AAP IMPLANTATE AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention