BEUDAMED
    FDA Adverse Event Summary report: N

    HTR-PMI MAKOWSKI LF BI FRT

    MDR report key: 1875222 · Received October 19, 2010

    Report

    Report Number
    1032347-2010-00178
    Date Received
    October 19, 2010
    Date of Event
    July 9, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    GXN
    PMA / PMN Number
    K924935
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INFORMATION PROVIDED, THE IMPLANTS DID NOT FIT AS EXPECTED DUE TO THE PATIENT HAVING MRS INFECTION, NOT BECAUSE OF THE MANUFACTURING OF THE IMPLANT. REVIEW OF DEVICE HISTORY RECORDS SHOW THAT LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. IF ADDITIONAL INFORMATION IS OBTAINED THAT ADDS VALUE TO THE RELEVANT CONTENT OF THIS REPORT AND/OR A CONCLUSION CAN BE DRAWN, A FOLLOW-UP REPORT WILL BE SENT.THERE WERE 2 IMPLANTS EXPLANTED, ALSO SEE MDR 1032347-2010-00179.

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON HAD DIFFICULTY IN GETTING THE CUSTOM IMPLANTS TO FIT PROPERLY. THIS RESULTED IN A 2 HOUR DELAY IN THE CASE. IT WAS LATER REPORTED SINCE THE IMPLANT WAS NOT FITTING PROPERLY, THE IMPLANTS WERE REMOVED ON (B)(6) 2010. PER THE INFORMATION PROVIDED THE UNDESIRED FIT WAS BECAUSE THE PATIENT HAD (B)(6) INFECTION, AND NOT DUE TO THE DESIGN OF THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HTR-PMI MAKOWSKI LF BI FRT HARD TISSUE REPLACEMENT/ PATIENT MATCHED IMPLANT GXN BIOMET MICROFIXATION 226050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization