BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES

    MDR report key: 5697462 · Received June 3, 2016

    Report

    Report Number
    0001032347-2016-00278
    Event Type
    Injury
    Date Received
    June 3, 2016
    Report Date
    May 13, 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
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BECAUSE THE LOT NUMBER IS UNKNOWN, THE DEVICE HISTORY RECORDS COULD NOT BE PULLED FOR REVIEW. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. 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. THIS IS REPORT 5 OF 7 FOR THE SAME EVENT. REPORT 1, THROUGH 4, 6, AND 7 ARE REPORTED ON MFR #0001032347-2016-00274 THROUGH 0001032347-2016-00277. 0001032347-2016-00279, AND 0001032347-2016-00280.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS OPENED DUE TMJ PARTS BEING INVOLVED IN A REVISION THAT WAS REPORTED AS THE RESULT OF A TUMOR THAT RETURNED IN THE PATIENTS JAW. THE SURGEON REPORTED THAT THE TMJ IMPLANTS LISTED IN THIS FILE WERE REMOVED BECAUSE THE PATIENT'S TUMOR RETURNED AND THE JOINT NEEDED TO BE REMOVED IN ORDER TO ACCESS THE JOINT. HE ALSO STATED THAT THERE WAS NO MALFUNCTION OF THE IMPLANTS AND CONFIRMED THAT THE PARTS WILL NOT BE RETURNED. THERE IS NO ALLEGED MALFUNCTION OF THE IMPLANT AND NO INDICATIONS THAT THE PART DID NOT FUNCTION AS INTENDED. THE MOST LIKELY UNDERLYING CAUSE OF THIS COMPLAINT IS PATIENT CONDITION. THE COMPLAINT IS CONFIRMED AS THE SURGEON STATED THAT IMPLANTS WERE REMOVED IN ORDER TO ACCESS THE TUMOR. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS FOR THESE PRODUCTS. THE FOLLOWING CORRECTIONS WERE IDENTIFIED: BRAND NAME WAS CORRECTED FROM 2.0 X 9 MM SELF-DRILLING IMF HEX SCREW TO BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES; CORRECTED FROM BONE SCREW TO 2.7X10MM HT X-DRIVE SCREW; CATALOG NUMBER WAS CORRECTED FROM 91-5609 TO 91-2710; CORRECTED FROM K983728 TO K113512. REPORT FIVE OF SEVEN FOR THE SAME EVENT, REFERENCE 0001032347-2016-00274-1 THROUGH 0001032347-2016-00280-1.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TMJ REVISION OCCURRED AS THE RESULT OF A TUMOR THAT RETURNED IN THE PATIENTS JAW. THERE WAS NO ALLEGATION OF IMPLANT FAILURE IN ORDER TO ACCESS THE TUMOR THE JOINT WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352509 BIOMET MICROFIXATION MANDIBULAR FRACTURE/ RECONSTRUCTION DEVICES 2.7X10MM HT X-DRIVE SCREW HWC BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R