BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CASPAR SELF-DRILLING DISTRACTION PIN

    MDR report key: 9750078 · Received February 25, 2020

    Report

    Report Number
    9750078
    Event Type
    Malfunction
    Date Received
    February 25, 2020
    Date of Event
    January 22, 2020
    Report Date
    January 28, 2020
    Manufacturer
    AESCULAP IMPLANT SYSTEMS, LLC
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TN
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    12MM DISTRACTION PIN USED WITH CASPAR RETRACTOR SHEARED OFF DURING PROCEDURE. THE DISTRACTION PIN SHEARED OFF FLUSH WITH THE CERVICAL BONE (C6) AND WAS UNABLE TO BE RETRIEVED BY THE SURGEON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213972 CASPAR SELF-DRILLING DISTRACTION PIN ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH AESCULAP IMPLANT SYSTEMS, LLC FF912SB 52547967

    Patients

    Seq Age Sex Outcome Treatment
    1 11315 DA