BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LANX SPINAL FIXATION SYSTEM

    MDR report key: 1947699 · Received December 29, 2010

    Report

    Report Number
    3004485144-2010-00057
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    November 30, 2010
    Report Date
    December 14, 2010
    Manufacturer
    LANX, INC.
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    ON (B)(6) 2010, IN PRE-OP EVALUATION, THE PT SHOWED SIGNS OF STENOSIS AT THE ABOVE ADJACENT LEVELS AND WAS SCHEDULED FOR A DECOMPRESSION SURGERY. THE PT HAD A PREVIOUS INSTRUMENTATION OF L5-S1 WITH PEDICLE SCREWS AND TLIF SPACER IN (B)(6) 2010. DURING INTRA-OPERATIVE IMAGING, THERE APPEARED TO BE A SLIGHT RADIOLUCENCY AT THE JUNCTION OF THE SPHERICAL HEAD AND SHANK OF BOTH OF THE S1 SCREWS. UPON INSPECTION, IT APPEARED THAT BOTH SCREWS HAD FRACTURED COMPLETELY THROUGH THE SHANK BUT HAD NOT MIGRATED. THE SCREWS WERE SUBSEQUENTLY REMOVED. UPON FURTHER EXAMINATION, IT WAS NOTED THAT THE PT HAD NOT FUSED AT L5-S1. THE REMAINING PORTION OF THE INITIAL CONSTRUCT WAS REMOVED EXCEPT FOR THE TLIF CAGE, FOLLOWED BY THE PLANNED DECOMPRESSION. THE PT WAS THEN INSTRUMENTED FROM L4 TO THE ILIUM WITH A TLIF CAGE AT L4-L5 AND SCREWS AND RODS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LANX SPINAL FIXATION SYSTEM SPINAL FIXATION SYSTEM KWQ LANX, INC. 7715-7545 LX2570

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention