BEUDAMED
    FDA Adverse Event Other Summary report: N

    RAYHACK OSTEOTOMY SYSTEMS

    MDR report key: 160803 · Received March 30, 1998

    Report

    Report Number
    1055920-1997-00002
    Event Type
    Other
    Date Received
    March 30, 1998
    Date of Event
    May 7, 1997
    Report Date
    March 25, 1998
    Manufacturer
    CREATIVE MEDICAL DESIGNS, INC.
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    2/18/97-SURGERY TO PERFORM AN ULNAR SHORTENING. 5/7/97-BROKEN PLATE DISCOVERED ON X-RAY. 3/26/97-THE PT STARTED IN A REMOBILIZATION AND STRENGTHENING PROGRAM. BONE UNION WAS NOT CONFIRMED. 5/20/97-REPLATING OF ULNAR BONE. 12/3/97-HEALING CONFIRMED. 12/3/97-SURGEON CONFIRMS IN LETTER THAT THE PT WAS PROBABLY OUT OF HIS SPLINT MUCH OF THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RAYHACK OSTEOTOMY SYSTEMS Implant ULNAR PLATE HRS CREATIVE MEDICAL DESIGNS, INC. ULNAR PLATE L 3455

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention