BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CART 9734056 S7 STAFF SHRT 100-120V INTL

    MDR report key: 8685675 · Received June 11, 2019

    Report

    Report Number
    1723170-2019-03164
    Event Type
    Malfunction
    Date Received
    June 11, 2019
    Date of Event
    May 23, 2017
    Report Date
    June 10, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PROBE 9733457 PEDICLE 2.25MM (SERIAL #: (B)(4)) FOUND PHYSICAL DAMAGE, AS THERE WAS A BENT INSTRUMENT TIP. AS REPORTED, THE TIP OF THE PROBE IS VISIBLY BENT. HOWEVER, WITH MARKERS ATTACHED AND FULLY SEATED, THE PROBE RETURNED GOOD GEOMETRY AND DIVOT ERROR READINGS. PRODUCT EVENT SUMMARY # (B)(4), DAMAGED 2.25MM PEDICAL PROBE. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9 733457, SERIAL/LOT #: (B)(4). 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 SYSTEM EVENT HAVING OCCURRED OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT A PEDICLE PROBE WAS DAMAGED AND HAD A BENT TIP. NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482872 CART 9734056 S7 STAFF SHRT 100-120V INTL INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9734056

    Patients

    Seq Age Sex Outcome Treatment
    1