BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OSTEOMED

    MDR report key: 88088 · Received April 30, 1997

    Report

    Report Number
    2027754-1997-00023
    Event Type
    Injury
    Date Received
    April 30, 1997
    Date of Event
    April 11, 1997
    Report Date
    April 25, 1997
    Manufacturer
    OSTEOMED CORP.
    Product Code
    HWW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE TIP OF THE CO SELF-GUIDED MANUAL COUNTER-SINK BROKE OFF DURING SURGERY. THE SURGEON SUCTIONED THE AREA EXTENSIVELY AND THE PIECE OF THE COUNTER SINK WAS RETRIEVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSTEOMED Implant MANUAL COUNTER SINK HWW OSTEOMED CORP. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention