BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1934440 · Received November 23, 2010

    Report

    Report Number
    3004485144-2010-00052
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    LANX, INC.
    Product Code
    MNI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. BASED ON INFO RECEIVED FROM THE INITIAL REPORTER, THE SURGEON DISCOVERED THAT THE PT HAD VERY HARD BONE. THE SURGEON BENT TWO TARGETING NEEDLES DURING HIS PREPARATION OF THE IMPLANT SITE. ALTHOUGH INCONCLUSIVE WITHOUT AN EVALUATION OF THE ACTUAL DEVICE, THE EXTRA FORCE NEEDED TO TAP INTO HARD BONE IS A LIKELY CONTRIBUTING FACTOR IN THE INSTRUMENT BREAKAGE.

    Description of Event or Problem · 1

    DURING A LUMBAR SPINAL FIXATION SURGERY, THE SURGEON BROKE OFF THE TIP OF A TAP IN THE PT'S PEDICLE. THE SURGEON WAS ABLE TO REMOVE THE TAP REMNANT. THE INCIDENT ADDED APPROXIMATELY 30 MINUTES TO THE SURGERY. PER THE INITIAL REPORTER, THERE WAS NO PT INJURY ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM MNI LANX, INC. 7706-1125 L515305

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention