BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HTR PMI RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT

    MDR report key: 6072988 · Received November 2, 2016

    Report

    Report Number
    0001032347-2016-00634
    Event Type
    Injury
    Date Received
    November 2, 2016
    Date of Event
    September 16, 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

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. HOWEVER, A ROOT CAUSE WAS IDENTIFIED DURING THE EVALUATION OF THE COMPLAINT FILE. THE PRODUCT IDENTITY WAS CONFIRMED IN THE REVIEW OF DEVICE HISTORY RECORDS DURING THE EVALUATION. ACCORDING TO THE COMPLAINT EVALUATION, BASED ON THE DATA AVAILABLE THROUGH THE REVIEW AND INVESTIGATION OF THE COMPLAINT FILE, THE MOST-LIKELY CAUSE WAS DETERMINED TO BE SURGEON TECHNIQUE. THE IFU (INSTRUCTIONS FOR USE) STATES ¿USING A POWERED INSTRUMENT, AN APPROPRIATELY SIZED PILOT HOLE MUST BE PLACED AT LEAST 4MM FROM THE PERIMETER OF THE IMPLANT BEFORE INSERTING ANY SCREW. IRRIGATION WHILE DRILLING IS RECOMMENDED.¿ IF THIS TECHNIQUE WAS NOT FOLLOWED IT COULD LEAD TO THE IMPLANT FRACTURING DURING PLATING. ACCORDING TO THE EVALUATION, THERE ARE NO INDICATIONS OF MANUFACTURING DEFECTS.

    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).

    Description of Event or Problem · 1

    (IN ADDITION TO WHAT WAS ALREADY REPORTED) MORE INFORMATION ABOUT THE SURGICAL TECHNIQUE WAS RECEIVED ON JAN 31, 2017. THE SALES ASSOCIATED REPORTED HE WAS PRESENT DURING THE PROCEDURE AND CONFIRMED THE PLACEMENT OF THE SCREWS WAS A MINIMUM OF 10 MM FROM THE EDGE OF THE IMPLANT AFTER THE FIRST CHOICE IMPLANT CRACKED AND CRUMBLED TO THE POINT WHERE IT WAS NOT IMPLANTABLE. THE SALES ASSOCIATE ADVISED THAT ON BOTH IMPLANTS, THE SURGEON DID NOT PRE-DRILL. HE REPORTED THAT WHEN THE SURGEON TRIED TO INSERT THE FIRST SCREW INTO THE BACKUP IMPLANT WITH A MANUAL DRIVER THE SCREW WOULD ONLY SPIN WITHOUT GRIPPING THE CORTICAL. THE SALES ASSOCIATE CONFIRMED HE BELIEVED THE SURGICAL TECHNIQUE WAS FOLLOWED BY THE SURGEON AND REITERATED THE CRUMBLING CONDITION OF THE IMPLANT.

    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
    724436 HTR PMI RIGHT FRONTAL SPHENOID PARIETAL TEMPORAL IMPLANT HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT (PMI) KKY BIOMET MICROFIXATION N/A 702830

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention