BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4 SL 4 HOLE L PLATE 100 DEG

    MDR report key: 2854082 · Received December 3, 2012

    Report

    Report Number
    0001032347-2012-00167
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    May 12, 2009
    Report Date
    November 9, 2012
    Manufacturer
    BIOMET MICROFIXATION
    Product Code
    HRS
    PMA / PMN Number
    PK011076
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE WARNINGS IN THE PACKAGE INSERT STATE THIS TYPE OF EVENT CAN OCCUR. WITHOUT A PRODUCT RETURN, NO PRODUCT EVALUATION IS ABLE TO BE CONDUCTED. THE LOT HISTORY OF THE IMPLANTED UNIT IS UNKNOWN, THEREFORE, THE DEVICE HISTORY RECORDS ARE UNABLE TO BE REVIEWED. 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

    THERE WAS A REPORT ON (B)(6) 2012 THAT STATED A PATIENT HAD A REVISION SURGERY FOR STERNALOCK BLU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 2.4 SL 4 HOLE L PLATE 100 DEG BONE PLATE HRS BIOMET MICROFIXATION N/A UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization