BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTR PMI RIGHT OCCIPITAL IMPLANT

    MDR report key: 6073091 · Received November 2, 2016

    Report

    Report Number
    0001032347-2016-00637
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    September 14, 2016
    Report Date
    October 3, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INTRAOPERATIVE FRACTURE OF THE IMPLANT IS A POSSIBLE ADVERSE EFFECT LISTED IN THE PACKAGE INSERT. NO PRODUCT WILL BE RETURNED TO THE MANUFACTURER FOR EVALUATION AS THE FIRST CHOICE IMPLANT WAS DISCARDED BY THE FACILITY AND THE SECOND CHOICE IMPLANT REMAINS IMPLANTED. REVIEW OF DEVICE HISTORY RECORDS SHOW THE LOT RELEASED WITH NO RECORDED ANOMALY OR DEVIATION. 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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS THAT THE IMPLANT WAS BRITTLE AND CRACKED DURING PLATING. THE COMPLAINT COULD NOT BE VERIFIED AS THE IMPLANT WAS NOT RETURNED. THE IMPLANT DIMENSIONAL ANALYSIS SCAN PERFORMED ON THE FC (FIRST CHOICE) AND BU (BACK UP) 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. BASED ON THE DATA AVAILABLE THROUGH THE REVIEW AND INVESTIGATION OF THIS FILE, THE MOST LIKELY UNDERLYING CAUSE IS SURGEON TECHNIQUE. THE IFU (INSTRUCTIONS FOR USE) STATES ¿USING A POWERED INSTRUMENT, AN APPROPRIATELY SIZED PILOT HOLE MUST BE PLACED AT LEAST 4 MM FROM THE PERIMETER OF THE IMPLANT BEFORE INSERTING ANY SCREW. IRRIGATION WHILE DRILLING IS RECOMMENDED.¿ THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS. DATE RECEIVED BY MFR, IF FOLLOW-UP, WHAT TYPE?, AND EVALUATION CODES WERE UPDATED BASED ON THE COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED A PMMA IMPLANT WAS TOO BRITTLE AND STRUGGLED TO ACCEPT A SCREW. WHEN THE SURGEON TRIED TO PLATE THE IMPLANT WITH 7MM SCREWS THE EDGES BEGAN TO CRUMBLE AND FALL APART. THE FIRST CHOICE IMPLANT AND THE BROKEN PIECES WERE REMOVED AND THE BACK UP IMPLANT WAS USED TO COMPLETE THE CRANIOTOMY. THIS PRESENTED A DELAY OF ABOUT FIFTEEN TO TWENTY MINUTES TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    724327 HTR PMI RIGHT OCCIPITAL IMPLANT HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT (PMI) KKY BIOMET MICROFIXATION N/A 705760

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention