BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINOUS PROCESS SHORT CLAMP

    MDR report key: 11258790 · Received February 1, 2021

    Report

    Report Number
    1723170-2021-00261
    Event Type
    Malfunction
    Date Received
    February 1, 2021
    Date of Event
    January 27, 2021
    Report Date
    February 1, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    OLO
    PMA / PMN Number
    K131425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICES WERE RETURNED TO MEDTRONIC FOR ANALYSIS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED INTRA/PERI-OPERATIVELY OF A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SURGEON DOES NOT LIKE THE GEN 3 CLAMPS. THE SURGEON TRIED THE TALLAND SHORT VERSIONS DURING THE CASE, BUT WAS UNABLE TO GET THE CLAMPS AROUND THE SPINOUS PROCESS. THE SURGEON ENDED UP ATTACHING WITH ONLY A FWE OF THE TEETH ENGAGED. THERE WAS A 5-7 MINUTE DELAY IN THE PROCEDURE AND NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156180 SPINOUS PROCESS SHORT CLAMP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC 9734716 200117

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR