BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARD TISSUE REPLACEMENT-PATIENT MATCHED-POSTERIOR PARIETAL OCCIPITAL IMPLANT

    MDR report key: 6215536 · Received December 30, 2016

    Report

    Report Number
    0001032347-2016-00787
    Event Type
    Injury
    Date Received
    December 30, 2016
    Date of Event
    December 9, 2016
    Report Date
    December 12, 2016
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    PMA / PMN Number
    PK924935
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE DEVICE HISTORY RECORDS SHOW THE LOT WAS RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. THE COMPLICATIONS IN THE INSTRUCTIONS FOR USE STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. 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

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A VALID CONCLUSION ABOUT THE CAUSE OF THIS EVENT. A FOLLOW UP REPORT WILL BE SENT UPON COMPLETION OF THE DEVICE EVALUATION.

    Additional Manufacturer Narrative · 1

    THIS IS REPORT ONE OF TWO FOR THE SAME EVENT. REPORT TWO OF TWO IS REPORTED ON MFR #0001032347-2016-00788.

    Additional Manufacturer Narrative · 1

    ONLY THE FIRST CHOICE (FC) IMPLANT WAS RETURNED, NOT THE BACKUP(BU). THE FIRST CHOICE IMPLANT WAS IN A BIOHAZARD CONDITION BUT OPENED AND REVIEWED IN THE CADAVER LAB. THE PART HAS A FRAGMENT MISSING. THE FRACTURE APPEARS TO BE THROUGH A PROFUSION HOLE, WHICH IS LIKELY WHERE THE USER ATTEMPTED TO INSERT A SCREW AND WHERE THE FRACTURE STARTED FROM. THE PROFUSION HOLES ARE DRILLED AT THE SAME DIAMETER AS A PRE-DRILLED HOLE FOR A SCREW, BUT THE PROFUSION HOLE IS DRILLED ALL THE WAY THROUGH THE IMPLANT WHERE A PRE-DRILLED HOLE IS DRILLED TO A DEPTH BASED ON THE SCREW. INSERTING THE SCREW INTO A PROFUSION HOLE RATHER THAN A PRE-DRILLED HOLE LIKELY CONTRIBUTED TO THE FRACTURE. THE BACKUP WAS NOT RETURNED, BUT IT WAS REPORTED THAT IT FRACTURED IN THE SAME MANNER. THE BACKUP IMPLANT IS NOT PROVIDED WITH PROFUSION HOLES. IF THE SURGEON DID NOT PRE-DRILL HOLES TO INSERT THE SCREWS, IT LIKELY WOULD HAVE CONTRIBUTED TO THE FRACTURE. THE IMPLANT DIMENSIONAL ANALYSIS SCAN PERFORMED ON THE FC AND BU IMPLANTS AS PART OF THE FINISHED PART INSPECTION PROCESS WERE REVIEWED. THE SCANS DETERMINED THAT BOTH THE FC AND BU IMPLANTS WERE MANUFACTURED ACCORDING TO DESIGN REQUIREMENTS PROVIDED BY THE CUSTOMER AND MET ALL ACCEPTANCE REQUIREMENTS. THE COMPLAINT WAS CONFIRMED AS A FRAGMENT HAS FRACTURED FROM THE RETURNED PART. THE MOST LIKELY CAUSE OF THE COMPLAINT IS PLATING TECHNIQUE. THIS SCREWS INVOLVED IN THIS EVENT, WHICH WERE REPORTED IN MFR #0001032347-2016-00788, WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE CUSTOM IMPLANTS (FIRST CHOICE AND BACKUP) FRACTURED WHILE INSERTING UNKNOWN SCREWS INTO THE PRESENT HOLES. IT IS REPORTED THE SURGEON COMPLETED THE SURGERY BY IMPLANTING A MESH. IT IS REPORTED THE EVENT CAUSED A TEN MINUTE DELAY. IT IS REPORTED THE PATIENT RETAINED A FOREIGN BODY. IT IS REPORTED THE POSITION IS OCCIPITAL.

    Description of Event or Problem · 1

    THE UNKNOWN SCREW HAS BEEN IDENTIFIED. IT IS REPORTED THE SURGEON COMPLETED THE SURGERY BY IMPLANTING A MESH ALONG WITH A SECOND CHOICE IMPLANT AND UNKNOWN PLATES. IT IS REPORTED THAT THE IMPLANT SOAKED FOR 2 MINUTES IN 0.9% NACL. IT IS REPORTED THAT A VISUAL INSPECTION WAS PERFORMED AND THERE WERE NO CONCERNS ABOUT USING THE IMPLANT. IT IS REPORTED THAT NO BONE WAS REMOVED TO COMPLETE THE PROCEDURE. IT IS REPORTED THAT THE SURGEON GUESSED THAT THE HOLES FOR DURA FIXATION WERE TOO CLOSE TO THE EDGES (LESS THAN 1 CM). IT IS REPORTED THAT ALL PIECES WERE REMOVED FROM THE PATIENT; THEREFORE, NO FOREIGN BODY WAS LEFT IN THE PATIENT. IT IS REPORTED, "THE PATIENT IS WELL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866535 HARD TISSUE REPLACEMENT-PATIENT MATCHED-POSTERIOR PARIETAL OCCIPITAL IMPLANT CUSTOM IMPLANT KKY BIOMET MICROFIXATION N/A 719200

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention