BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1.5X4MM HT SD X-DR SCREW

    MDR report key: 5412903 · Received February 5, 2016

    Report

    Report Number
    0001032347-2016-00027
    Event Type
    Injury
    Date Received
    February 5, 2016
    Date of Event
    December 15, 2015
    Report Date
    January 8, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    JEY
    PMA / PMN Number
    PK121589
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT CANNOT BE VERIFIED AS NONE OF THE PARTS WERE RETURNED FOR EVALUATION. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT CANNOT BE DETERMINED AS THE PARTS WERE NOT RETURNED FOR EVALUATION. THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. THE IFU (INSTRUCTIONS FOR USE) STATES ¿LATE POSTOPERATIVE COMPLICATIONS CAN INCLUDE: FRACTURE OF THE DEVICE DUE TO TRAUMATIC INJURY, LOOSENING OR MIGRATION DUE TO LOSS OF FIXATION OR TRAUMA¿. SUPPLEMENTAL REPORT FOUR OF FOUR FOR THE SAME EVENT, SEE ALSO 0001032347-2016-00024-1 THROUGH 00026-1.

    Additional Manufacturer Narrative · 1

    REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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. REPORT FOUR OF FOUR FOR THE SAME EVENT, SEE ALSO 0001032347-2016-00024 THROUGH 00026.

    Description of Event or Problem · 1

    THE SALES ASSOCIATE REPORTED A REVISION DUE TO DISPLACEMENT OF THE IMPLANT. IT WAS REPORTED AT THE INITIAL SURGERY THE PRE-PLATED SCREWS WERE ALL LOOSE, IN THE PACKAGING. AFTER INITIAL PROCEDURE A CT SCAN SHOWED THAT THE IMPLANT WAS PRESSED OUT TEMPOROBASAL. THE SURGEON DECIDED TO PERFORM REVISION SURGERY. DURING THE REVISION SURGERY IT WAS OBSERVED THAT THE PLATING HAD BROKEN OUT OF THE IMPLANT. THE BACKUP HTR-PMI IMPLANT WAS USED DURING THE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72240 1.5X4MM HT SD X-DR SCREW SCREW JEY BIOMET MICROFIXATION N/A 504460

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R