BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCULAN 3TI SMALL DRILL

    MDR report key: 6640240 · Received June 14, 2017

    Report

    Report Number
    9610612-2017-00332
    Event Type
    Malfunction
    Date Received
    June 14, 2017
    Date of Event
    May 24, 2017
    Report Date
    June 13, 2017
    Manufacturer
    AESCULAP IMPLANT SYSTEMS
    Product Code
    HWE
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.

    Description of Event or Problem · 0

    COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THERE WAS BLACK CONTAMINATION FROM THE MACHINE DURING OILING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421040 ACCULAN 3TI SMALL DRILL POWER SYSTEMS ORTHOPAEDICS HWE AESCULAP IMPLANT SYSTEMS GA671 51486252

    Patients

    Seq Age Sex Outcome Treatment
    1 Other