BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT

    MDR report key: 5067524 · Received September 10, 2015

    Report

    Report Number
    0001032347-2015-00392
    Event Type
    Injury
    Date Received
    September 10, 2015
    Date of Event
    July 15, 2015
    Report Date
    August 12, 2015
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    PMA / PMN Number
    PK924935
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS REPORTED THERE ARE NO PICTURES OR PIECES OF THE IMPLANTS TO RETURN FOR EVALUATION. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE PACKAGE INSERT STATES INTRAOPERATIVE AND EARLY POSTOPERATIVE COMPLICATIONS CAN INCLUDE FRACTURE OF THE IMPLANT. IN ADDITION, THE INSERT STATES "THESE DEVICES ARE USED FOR AUGMENTING AND CONTOURING BONE. THEY ARE NOT INTENDED OR DESIGNED FOR FULL OR PARTIAL LOAD BEARING." 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.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT THAT THE IMPLANT WAS FRAGILE AND CRACKED DURING MODIFICATION COULD NOT BE VERIFIED AS THE IMPLANT WAS NOT RETURNED AND SUCCESSFULLY IMPLANTED. THE IMPLANT DESIGN WAS REVIEWED AND IDENTIFIED THE IMPLANTS WERE MANUFACTURED ACCORDING TO DESIGN REQUIREMENTS PROVIDED BY THE CUSTOMER AND MET ALL ACCEPTANCE REQUIREMENTS. BASED ON THE DATA AVAILABLE THROUGH THE REVIEW AND INVESTIGATION OF THIS FILE, THE MOST LIKELY UNDERLYING CAUSE IS SURGEON TECHNIQUE AND SURGEON PREFERENCE.

    Description of Event or Problem · 1

    THE SURGEON REPORTED THE FIRST CHOICE IMPLANT AND THE BACK-UP IMPLANT BOTH BROKE DURING THE SURGERY. HE REPORTED THE FIT OF THE IMPLANT WAS NOT GOOD OVERALL, AND THE ZYGOMATIC ARCH PART BROKE WITH A LITTLE PRESSURE OF THE FINGER. AS THE SURGEON WAS TRYING TO MODIFY THE IMPLANTS WITH A RONGEUR OVER THE TABLE, THE IMPLANTS CRACKED AT DIFFERENT PLACES. THE SURGEON WAS ABLE TO USE A BIG PART OF ONE OF THE IMPLANTS AND USED ACRYLIC CEMENT ON THE REMAINING DEFECT. THERE WAS AN APPROXIMATE SURGICAL DELAY OF TWO HOURS. IT IS REPORTED THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597962 HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT HTR-PMMA KKY BIOMET MICROFIXATION N/A 611340

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization