BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISTAL TARGETING DEVICE R1.5

    MDR report key: 2483700 · Received February 22, 2012

    Report

    Report Number
    9610622-2012-00088
    Event Type
    Malfunction
    Date Received
    February 22, 2012
    Date of Event
    February 8, 2012
    Report Date
    February 8, 2012
    Manufacturer
    STRYKER OSTEOSYNTHESIS KIEL
    Product Code
    LXH
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADD'L INFO WILL BE REPORTED IN A SUPPLEMENTAL REPORT. ASSOCIATED DEVICE ARE 1320-5330 FIXATION BOLT 9X50 MM LOT# K283814, 1320-0100, TARGET DEVICE: 300X160MM, LOT #KME902044.

    Description of Event or Problem · 1

    ON (B)(6) 2012, GAMMA3 DTS OPERATION WAS PERFORMED. WHEN CONNECTING THE DISTAL TARGETING ARM AND GAMMA3 TARGETING DEVICE, FIXING BOLTS COULD NOT BE INSERT COMPLETELY. THE SALE REP WHO OBSERVED THE OPERATION THOUGHT NO PROBLEM IN THE CONNECTION PROCEDURE. THE SURGEON FIXED THE ASSEMBLE WITH THE TAPE. HE CONTINUED THE SURGERY WHILE HOLDING THE ASSEMBLE AND THE OPERATION WAS FINISHED SOMEHOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISTAL TARGETING DEVICE R1.5 INSTRUMENT LXH STRYKER OSTEOSYNTHESIS KIEL NA KP340967

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other