BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4261133 · Received November 19, 2014

    Report

    Report Number
    0001032347-2014-00396
    Event Type
    Injury
    Date Received
    November 19, 2014
    Date of Event
    October 28, 2014
    Report Date
    November 19, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    KKY
    PMA / PMN Number
    PK924935
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. 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 WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. THE USER FACILITY IS FOREIGN; THEREFORE A FACILITY MEDWATCH REPORT WILL NOT BE AVAILABLE. THE DESIGN AND INSPECTION SCANS WERE REVIEWED AND THE IMPLANTS WERE FOUND TO BE MANUFACTURED ACCORDING TO THE DESIGN REQUIREMENTS. THE MOST LIKELY UNDERLYING CAUSE OF THE COMPLAINT IS PATIENT MOVEMENT ON THE CT SCAN USED FOR DESIGN OF THE IMPLANT. THE SURGEON CHOSE TO APPROVE THE USE OF THE SCAN. THE ORIGINAL REPORT STATED THE DEVICE WOULD BE EVALUATED, THE IMPLANT WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    HTR PMI IMPLANT DID NOT FIT AND HAD TO BE ALTERED DURING SURGERY. ADDITIONAL INFORMATION WAS RECEIVED SUGGESTING THAT PATIENT MOVED DURING THE INITIAL CT SCAN FOR THE CUSTOM IMPLANT AND THAT THE POST OP CT DID NOT MATCH THE INITIAL CT. THE BACK UP AND SKULL MODEL WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749638 HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT HTR-PMI IMPLANT PMMA/PHEMA/CA 1PIECE KKY BIOMET MICROFIXATION N/A N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other