BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAV THORACIC PROBE TIP

    MDR report key: 4042971 · Received August 27, 2014

    Report

    Report Number
    1723170-2014-00904
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    July 29, 2014
    Report Date
    November 10, 2015
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    OLO
    PMA / PMN Number
    K124004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE DISTAL 10MM OF LUMBAR PROBE WAS TWISTED. THE CORRECT CATALOG NUMBER OF THE LUMBAR PROBE TIP WAS 9734679. THE LOT NUMBER WAS 120525. THE SITE WILL NOT RETURN THE PARTS FOR EVALUATION. THE DEVICE MANUFACTURE DATE WAS (B)(4) 2012. DEVICE NOT RETURNED TO MANUFACTURER.

    Additional Manufacturer Narrative · 1

    CORRECTIONS: CORRECTED TO SERIOUS INJURY. ADDITIONAL INFORMATION: THERE WAS AN ADDITIONAL SPINE INSTRUMENT REPORTED TO BE DAMAGED DURING THE SAME PATIENT EVENT. A LUMBAR PROBE WAS TWISTED DURING CLINICAL USE. THE DETAILS OF THE DEVICE ARE AS FOLLOWS: BRAND NAME = LUMBAR PROBE TIP. PROCODE = HAW. CATALOG# = 9734402. 510K = K050438. MECHANICAL ENGINEERING REVIEWED THE COMPOSITION OF THE THORACIC PROBE FRAGMENT AND FOUND IT TO BE 17-4 STAINLESS STEEL. PER THE TOXICOLOGICAL RISK ASSESSMENT FOR THIS MATERIAL, "THE LARGE MARGIN OF SAFETY FOR THESE ELEMENTS INDICATES THAT THE WORST CASE EXPOSURE TO THE LEACHABLES FROM THE 17-4H STAINLESS STEEL PIECE LEFT IN THE VERTEBRAL BONE IS MUCH LOWER THAN THE TOLERANCE LIMITS OF THE HUMAN BEINGS. THUS, NO ADVERSE EFFECTS OR CHEMICAL TOXICITY ARE EXPECTED FROM THESE LEACHABLE METALS FROM THE STAINLESS STEEL PIECE."

    Additional Manufacturer Narrative · 1

    ON 11/03/2014, VOLUNTARY MEDWATCH REPORT #MW5037639 WAS RECEIVED BY THE MANUFACTURER. THIS REPORT WAS FOUND TO BE ASSOCIATED WITH PREVIOUSLY SUBMITTED MDR# 1723170-2014-00904 AND CONTAINED THE FOLLOWING ADDITIONAL DETAILS: EVENT DESCRIPTION: "PATIENT UNDERGOING LUMBAR SURGERY, WITH TRANSPEDICULAR SCREW PLACEMENT AT L5. WHEN UTILIZING AN EXTRA SHARP PADDLE PROBE VERY HIGH DENSITY BONE WITH OSTEOPETROSIS WAS ENCOUNTERED MAKING IT EXTREMELY DIFFICULT TO REMOVE THE PROBE. STRONG MECHANICAL EFFORT WAS USED TO REMOVE THE PROBE AT WHICH POINT IT BROKE LEAVING A PIECE OF 1 1/4 INCHES LODGED IN THE IN THE VERTEBRAL BODY AT THE L5 PEDICLE ON THE RIGHT SIDE. STRAIGHT LUMBAR PROBE WAS PREVIOUSLY USED AND TIP BECAME BENT. STRAIGHT THORACIC PROBE WAS THEN USED WHICH BROKE OFF. " THE LOT NUMBER OF THE LUMBAR PROBE TIP (P/N 9734679) WAS LISTED ON THE MEDWATCH AS 120223 WHICH DIFFERED THAN THE PREVIOUSLY REPORTED LOT NUMBER PROVIDED BY THE ONSITE REP. LOT NUMBER 120223 CORRESPONDED TO A MANUFACTURE DATE OF 23-FEB-2012. THIS NEW LOT NUMBER COULD NOT BE VERIFIED AS THE SITE DECLINED TO RETURN THE DEVICE. BASED ON THE ADDITIONAL EVENT DESCRIPTION ABOVE, THE MOST LIKELY CAUSE OF THE REPORTED INCIDENT WAS OVER-TORQUING THE DEVICE DURING USE ON A PATIENT WITH "VERY HIGH DENSITY BONE."

    Additional Manufacturer Narrative · 1

    CORRECTION: ON 13-OCT-2015, IT WAS NOTICED THAT A PREVIOUS MDR SUBMISSION CONTAINED INCORRECT INFORMATION WITH REGARDS TO THE COMMON DEVICE NAME, PRODUCT CODE AND/OR PMA/510(K). THIS MDR IS BEING SUBMITTED TO CORRECT THIS INFORMATION. THERE IS NO NEW INFORMATION TO CHANGE THE PATIENT INFORMATION, EVENT DESCRIPTION OR MANUFACTURER NARRATIVE THAT WAS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT MADE AVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE, FOLLOWING-UP AT THE SITE, REPORTED THE PATIENT IS DOING FINE. NO FURTHER DETAILS WERE AVAILABLE FROM THE SITE. RMA ISSUED. REPLACEMENT THORACIC PROBE SHIPPED TO SITE (B)(4) 2014. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, A THORACIC PROBE WAS DAMAGED. APPROXIMATELY 30MM OF THE THORACIC PROBE BROKE OFF IN THE PATIENT; THE SURGEON WAS UNABLE TO REMOVE THE PIECE FROM THE PATIENT. NO FURTHER DETAILS REGARDING THE DAMAGE, OR HOW IT OCCURRED, WERE PROVIDED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    522591 NAV THORACIC PROBE TIP ORTHOPEDIC STEREOTAXIC INSTRUMENT OLO MEDTRONIC NAVIGATION, INC. 120223

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention