BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 4243518 · Received November 11, 2014

    Report

    Report Number
    0001032347-2014-00394
    Event Type
    Injury
    Date Received
    November 11, 2014
    Report Date
    November 11, 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
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. 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.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE PUBLISHED IN SURGICAL NEUROLOGY INTERNATIONAL REFERENCED A REVISION DUE TO "PERSISTENT LOCAL INFECTION". THREE (3) YEARS AFTER SUFFERING SEVERE HEAD TRAUMA, THE PATIENT UNDERWENT A CRANIOPLASTY DUE TO PROGRESSIVE RESORPTION OF HER CRANIAL FLAP AND A PMMA IMPLANT WAS USED TO REPLACE HER NATIVE BONE. EIGHT (8) YEARS AFTER THE PART WAS IMPLANTED, THE PATIENT "PRESENTED AFTER SUSTAINING A SMALL TRAUMATIC LACERATION OVER HER CRANIAL IMPLANT AT THE VERTEX, WHICH EXPOSED A SMALL PORTION OF THE PLATE". THE IMPLANT WAS REMOVED DUE TO "PERSISTENT LOCAL INFECTION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    726840 HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANT PMMA IMPLANT KKY BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization| R