BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5 MM HEX HEAD SCREW X 38MM

    MDR report key: 6184474 · Received December 18, 2016

    Report

    Report Number
    0009617840-2016-00044
    Event Type
    Injury
    Date Received
    December 18, 2016
    Date of Event
    November 25, 2016
    Report Date
    December 15, 2016
    Manufacturer
    ZIMMER CAS
    Product Code
    OLO
    PMA / PMN Number
    PK141601
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IDENTIFICATION NECESSARY TO REVIEW MANUFACTURING HISTORY WAS NOT PROVIDED. CURRENT INFORMATION IS INSUFFICIENT TO PERMIT A CONCLUSION AS TO THE CAUSE OF THE EVENT.

    Description of Event or Problem · 1

    DURING AN INITIAL KNEE ARTHROPLASTY PROCEDURE, A SCREW FRACTURED OFF AND FELL INTO THE PATIENT. THE SCREW WAS UNABLE TO BE REMOVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835179 3.5 MM HEX HEAD SCREW X 38MM ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO ZIMMER CAS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other