BEUDAMED
    FDA Adverse Event Other Summary report: N

    OPTEFORM ALLOGRAFT DISC

    MDR report key: 589176 · Received April 8, 2005

    Report

    Report Number
    3002719998-2005-00004
    Event Type
    Other
    Date Received
    April 8, 2005
    Date of Event
    January 7, 2005
    Report Date
    April 8, 2005
    Manufacturer
    REGENERATION TECHNOLOGIES, INC.
    Product Code
    LMO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT UNDERWENT A REPAIR OF A NON-UNION HEEL FRACTURE. 7-10 POST SURGERY THE PATIENT EXPERIENCED AN INFLAMMATORY RESPONSE WHICH THE PHYSICIAN TREATED WITH IV ANTIBIOTICS. CULTURES WERE TAKEN; LAB WORK WAS OK. AT THIS TIME THE PATIENT IS STILL PRESENTING WITH A RED, INFLAMMATORY RESPONSE", PER COMPLAINT FORM. THE ALLOGRAFT WAS IMPLANTED IN 2004. THE SURGEON INDICATED THAT THE SURGEON INDICATED THAT THE SURGERY SITE WAS NOT CULTURED AND THE PT IS CURRENTLY ON STEROID THERAPY. PATIENT HAS UNDERGONE A PREVIOUS SURGERY THAT DID NOT HEAL PROPERLY DUE TO PATIENT NON-COMPLIANCE, WHICH WARRANTED THIS PROCEDURE UTILIZING THE OPTEFORM ALLOGRAFT DISC AND A DISTAL TIBIA AUTOGRAFT. THE SURGERY SITE FROM THE AUTOGRAFT WAS WITHOUT SIGNS OR SYMPTOMS OF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OPTEFORM ALLOGRAFT DISC ALLOGRAFT PASTE LMO REGENERATION TECHNOLOGIES, INC. 002545 101031736

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention