BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIO-INTRAFIX SCREW

    MDR report key: 1963393 · Received January 14, 2011

    Report

    Report Number
    1221934-2011-00011
    Event Type
    Injury
    Date Received
    January 14, 2011
    Report Date
    January 7, 2011
    Manufacturer
    DEPUY MITEK
    Product Code
    MBI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOTHING IS BEING RETURNED, THE ACTUAL DEVICE IS NOT DEFINED AND NO LOT IDENTIFICATION HAS BEEN SUPPLIED. REACTION TO DEVICE WAS 18 MONTHS POST OPERATIVELY; A FOREIGN BODY REACTION. POST-OP LABS SUGGEST A REACTION TO THE DEVICE. REACTIONS TO ABSORBABLE DEVICES IS RARE, HOWEVER, THERE IS A SMALL PORTION OF THE POPULATION THAT MAY FOR WHATEVER REASON HAVE THIS TYPE OF EXPERIENCE IN RESPONSE TO A FOREIGN BODY; THE FIXATION DEVICE. THIS IS A HISTORICAL AND THIS REPORT IS BEING FILED TO DOCUMENT THE ADVERSE EVENT. AT THIS POINT IN TIME, NO CORRECTIVE OR FURTHER ACTION IS WARRANTED, HOWEVER, THIS FILE WILL REMAIN RECEPTIVE TO ANY POTENTIAL FUTURE INFO RECEIVED THAT IS RELATIVE AND GERMANE TO THIS ISSUE. ALSO MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD.

    Description of Event or Problem · 1

    A SURGEON WAS REPORTING THAT ONE OF HIS PTS HAD A SUCCESSFUL AND UNEVENTFUL ACL RECONSTRUCTION APPROX 18 MONTHS AGO WITH THE USE OF AN ALLOGRAFT (MFG. AND LOT UNDEFINED), FIBERWIRE (CATALOG AND LOT UNDEFINED) AND A MITEK BIO-INTRAFIX (CATALOG AND LOT UNDEFINED) FOR FIXATION. AT 6 MONTHS POST OP IMAGES WERE REVIEWED THAT INDICATED ALL WAS FINE. AT 18 MONTHS POST-OP, THE PT PRESENTED WITH PAIN (NO INFECTION) AROUND THE TIBIAL TUNNEL, 3 WEEKS DURATION. THE SURGEON DOES NOT KNOW WHAT THE UNDERLYING CAUSE FOR THIS IS; HE IS PERFORMING DUE DILIGENCE AND IS REACHING OUT FOR DATA OF POSSIBLE SIMILAR PAST ISSUES WITH INVOLVED DEVICES. AT THIS POINT IN TIME, 18 MONTHS POST-OP, THE PT UNDERWENT A RE-SURGERY; THE SURGEON NOTED THAT THERE WAS A CYSTIC TYPE OF REACTION AROUND THE FIXATION DEVICE AND SO THE DEVICE WAS REMOVED. THE SURGEON EMPLOYED BONE GRAFTING TO ADDRESS THE DEFECT. THE ORIGINAL REPAIR APPEARED OK AND WAS LEFT ALONE, ALSO NO OTHER FIXATION DEVICE WAS NEEDED. CULTURES WERE SENT OFF FOR LABS; RESULTS POINT TOWARDS A FOREIGN BODY REACTION. THERE IS NOTHING BEING RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN BIO-INTRAFIX SCREW SOFT TISSUE FIXATION DEVICE MBI DEPUY MITEK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention