BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMBAR CURVED LENKE GEAR SHIFT

    MDR report key: 7463925 · Received April 26, 2018

    Report

    Report Number
    3010197239-2018-00006
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Date of Event
    March 27, 2018
    Report Date
    April 20, 2018
    Manufacturer
    CAMBER SPINE TECHNOLOGIES
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE SURGEON ATTEMPTED TO REMOVE THE FRACTURED PROBE FRAGMENT (APPROX. 35 MM IN LENGTH) AND WAS UNSUCCESSFUL DUE TO THE PATIENT'S SCLEROTIC BONE. IT WAS REPORTED THAT THE SURGEON HAD PREVIOUSLY USED THE CURVED LENKE PROBE EARLIER IN THIS PROCEDURE TO AID WITH SCREW INSERTION AT THE L5 AND S1 LOCATIONS ON THE RIGHT SIDE AND L5 ON THE LEFT SIDE AS INTENDED WITH NO COMPLICATIONS. THE SURGEON COMPLETED THE PROCEDURE BY USING A STRAIGHT LENKE PROBE IN A MORE MEDIAL LOCATION AT THE LEFT S1 TO PLACE A SCREW SYSTEM WITH NO ADDITIONAL COMPLICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A CAMBER SALES REP THAT THE CAMBER LUMBAR CURVED LENKE GEAR SHIFT INSTRUMENT (I.E., PEDICLE PROBE) (CP-129-29, BR08915B) FRACTURED AT THE LEFT S1 LOCATION DURING AN L5-S1 POSTERIOR PEDICLE SCREW FIXATION SURGERY. THE SURGEON WAS UNABLE TO REMOVE THE FRACTURED PORTION OF THE PROBE FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307472 LUMBAR CURVED LENKE GEAR SHIFT PEDICLE PROBE LXH CAMBER SPINE TECHNOLOGIES CP-129-29 BR08915B

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR