BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SSI INSERTER

    MDR report key: 5056011 · Received September 4, 2015

    Report

    Report Number
    0001825034-2015-03867
    Event Type
    Injury
    Date Received
    September 4, 2015
    Date of Event
    August 17, 2015
    Report Date
    August 17, 2015
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    LKD
    PMA / PMN Number
    PCUSTOM
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON (B)(6) 2015. DURING THE PROCEDURE, A G7 SSI CURVED IMPACTOR FRACTURED. A PIECE OF THE FRACTURED INSERTER FELL IN THE PATIENT AND WAS REMOVED. THERE WAS A SLIGHT DELAY. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586750 SSI INSERTER INSTRUMENT, HIP LKD BIOMET ORTHOPEDICS N/A RDWO41557

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R