BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERNALOCK BLU BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM

    MDR report key: 4151154 · Received October 8, 2014

    Report

    Report Number
    0001032347-2014-00347
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    October 3, 2014
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK110574
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REP REPORTED THAT THE COMPLAINT ITEM WAS DISCARDED DURING THE REVISION SURGERY AND THEREFORE NOT AVAILABLE FOR REVIEW BY THE MANUFACTURER. WITHOUT A KNOWN LOT NUMBER, REVIEW OF THE MANUFACTURING RECORDS CANNOT BE PERFORMED. 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. FILE 1 OF 2.

    Description of Event or Problem · 1

    DISTRIBUTOR REPORTED A REVISION DUE TO THE LOOSENING OF THE SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633483 STERNALOCK BLU BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM UNKNOWN STERNALOCK SCREW HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R