BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SPINAL SYSTEM

    MDR report key: 12922569 · Received December 3, 2021

    Report

    Report Number
    1030489-2021-01495
    Event Type
    Malfunction
    Date Received
    December 3, 2021
    Date of Event
    May 11, 2021
    Report Date
    December 3, 2021
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    HXX
    UDI-DI
    00643169086159
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED SUMMARY- VISUAL INSPECTION CONFIRMED THE TORX TIP OF THE DRIVER HAS BEEN DAMAGED. THE TORX EDGES HAVE BEEN ROUNDED OFF/DEFORMED. FUNCTIONAL INSPECTION WITH A SAMPLE BONE SCREW CONFIRMED THE DRIVER WAS ABLE TO ENGAGE AND THREAD INTO THE SCREW WITHOUT ANY ISSUE. THIS TYPE OF DAMAGE IS CONSISTENT WITH TORSIONAL OVERLOAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM HEALTHCARE PROFESSIONAL VIA FIELD REPRESENTATIVE REGARDING PATIENT WITH SYMPTOMS OF OYL (OSSIFICATION OF YELLOW LIGAMENT) INVOLVED IN CRIMPING THE SCREW STRONGER THAN USUAL. LEVELS IMPLANTED - T2-5. IT WAS REPORTED THAT INTRA-OPERATIVELY, THOUGH THE SCREW WAS ATTACHED TO THE SCREWDRIVER, THERE WAS TOO MUCH LOOSENESS AT THE TIP, AND IT COULD NOT BE ATTACHED SQUARELY. PRODUCT WAS USED CORRECTLY ACCORDING TO THE DIRECTIONS GIVEN IN THE IFU/LABELING. EVENT WAS ASSOCIATED WITH THE PATIENT. ADDITIONAL TREATMENT/SURGERY PERFORMED TO REINSERT THE SCREW. THERE WAS DELAY IN OVERALL PROCEDURE TIME FOR LESS THAN 60 MINUTES. NO HEALTH DAMAGE IN THE PATIENT WAS REPORTED. ON 2021-MAY-11, RECEIVED ADDITIONAL INFORMATION THAT S5 (RMAS) WAS USED FOR UPPER THORACIC SPINE FIXATION. EVEN THOUGH THE TIP WAS ALIGNED WHEN CONNECTING THE SCREW TO THE CNRMAS LS SCREWDRIVER (5584332), THERE IS A LOT OF LOOSENESS, AND IT WAS DIFFICULT TO ATTACH IT STRAIGHT. SINCE THERE WAS A LOT OF LOOSENESS FROM THE BEGINNING, EVEN THOUGH THE SLEEVE WAS SQUEEZED TIGHTLY WITH CLEANING RAGS AND WAS CRIMPED, IT WAS DIFFICULT TO TURN THE SLEEVE AND ATTACH IT STRAIGHT. WHEN THE RMAS SCREW WAS ATTACHED TO THE DRIVER TO INSERT IT, IT WAS DIFFICULT TO INSERT THE RMAS SCREW BECAUSE THE AXIS OF THE BONE SCREW OF THE RMAS SCREW AND THE AXIS OF THE DRIVER SHAFT WERE MISALIGNED, AND THEY COULD NOT BE ATTACHED STRAIGHTLY. THE DRIVER AND RMAS SCREW WERE ATTACHED TIGHTLY, BUT IT DIDN'T IMPROVE. ALTHOUGH IT WAS IN SUCH A STATE, IT WAS SAID THAT IT HAS MANAGED TO PLACE THE RMAS SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1827294 CD HORIZON® SPINAL SYSTEM SCREWDRIVER HXX MEDTRONIC SOFAMOR DANEK USA, INC 5584332 CT12G009 00643169086159

    Patients

    Seq Age Sex Outcome Treatment
    1 Male