BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMBERT-LOWMAN BONE CLAMP 8

    MDR report key: 2438544 · Received January 13, 2012

    Report

    Report Number
    2523190-2012-00008
    Event Type
    Malfunction
    Date Received
    January 13, 2012
    Report Date
    January 13, 2012
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    GDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    SURGEON INITIALLY REPORTED THAT A "BROKEN RIM UNION" OF THE DEVICE OCCURRED DURING SURGERY AT THE FIRST USE. ON (B)(6) 2012, SURGEON REPORTS VIA E-MAIL THAT HE WAS PERFORMING A CLOSED REDUCTION OF A FRACTURED HIP (USING A C-ARM), AND FIXATION USING A COMPRESSION SCREW. THE SURGEON CANNOT ARTICULATE THE ACTUAL ISSUE WITH THE DEVICE BEYOND "BROKEN RIM UNION". HE REPORTS NO HARM TO THE PATIENT, NO DELAY IN SURGERY, NO PROBLEM WITH TREATMENT OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMBERT-LOWMAN BONE CLAMP 8 NA GDJ INTEGRA YORK, PA INC. 732591811/732566511

    Patients

    Seq Age Sex Outcome Treatment
    1