BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7X12MM HT X-DRIVE SCREW

    MDR report key: 5846891 · Received August 4, 2016

    Report

    Report Number
    0001032347-2016-00375
    Event Type
    Injury
    Date Received
    August 4, 2016
    Date of Event
    June 7, 2016
    Report Date
    July 7, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HWC
    PMA / PMN Number
    PK113512
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE AT THIS TIME THE MOST LIKELY ROOT CAUSE OF THE EVENT IS THE PATIENT'S CONDITION. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION. REPORT FOUR OF FOUR FOR THE SAME EVENT, REFERENCE 1032347-2016-00372 THROUGH 1032347-2016-003734.

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE RETURNED FOR EVALUATION. THE PRODUCT IDENTITIES WERE CONFIRMED IN THE EVALUATION. A VISUAL INSPECTION REVEALED A BONY INGROWTH ON THE MANDIBLE IMPLANT, MINOR SCRATCHES ON THE SURFACE OF THE IMPLANT WHERE THE SCREWS WERE INSERTED, AND MINOR WEAR ON THE ANODIZE COATING AROUND THE HEAD OF THE SCREWS. BECAUSE THE IMPLANTS WERE REVISED DUE TO THE ABSCESSED FISTULA, THE COMPLAINT IS CONFIRMED. THE MOST-LIKELY CAUSE WAS DETERMINED TO BE PATIENT'S CONDITION. THE NON-CONFORMANCE DATABASE WAS REVIEWED IN THE EVALUATION FOR THE MANDIBLE IMPLANT AND NO NON-CONFORMANCES WERE FOUND. THE LOT NUMBERS FOR THE SCREWS ARE STILL UNKNOWN, THEREFORE, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED IN THE EVALUATION. ACCORDING TO THE EVALUATION, THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THIS IS REPORT FOUR OF FOUR FOR THE SAME EVENT. REPORTS ONE THROUGH THREE ARE REPORTED ON MFR #0001032347-2016-00372-1 THROUGH 0001032347-2016-00374-1.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED THE JOINT WAS IMPLANTED (B)(6) 2014 AND A REVISION DUE TO INFECTION WAS PERFORMED ON (B)(6) 2016. IT WAS REPORTED THE JOINT REMAINED IMPLANTED WITH NO ISSUES, THEN AT SOME POINT IN THE PAST COUPLE OF MONTHS AN ABSCESSED FISTULA DEVELOPED ON THE PATIENTS RIGHT JAW. THE SURGEON FOUND THE ABSCESS CREATED A LOOSENING OF THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498845 2.7X12MM HT X-DRIVE SCREW SCREW HWC BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R