BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTURE ANTERIOR CERVICAL PLATE SYSTEM

    MDR report key: 3835399 · Received May 28, 2014

    Report

    Report Number
    1030489-2014-02640
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    April 28, 2014
    Report Date
    April 28, 2014
    Manufacturer
    MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS
    Product Code
    KWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PRODUCT ANALYSIS: VISUALLY AND MICROSCOPIC EXAMINATION OF THE THREE BONE SCREWS IDENTIFIED ROUNDED HEX CORNERS ON THE HEAD OF THE SCREWS. FUNCTIONAL EVALUATION OF SCREWS WITH A SAMPLE DRIVER AND SIMULATED BONE FOUND SCREWS WERE UNABLE TO BE FULLY ENGAGED, DUE TO THE DRIVER TIP DISENGAGING, CONSISTENT WITH STRIPPING. ALL THREE OF THE BONE SCREWS IDENTIFIED OUTER HEAD DAMAGE AND DEFORMATION, CONSISTENT WITH MIS-LOCATING THE SCREWS DURING ATTEMPTED INSERTION. DUE TO THE OFF-CENTER LOCATION OF THE SCREWS, THE HEADS OF THE SCREWS APPEAR TO HAVE BEEN DRIVEN INTO THE BODY OF THE ANTERIOR CERVICAL PLATE DURING ATTEMPTED INSERTION, THUS INCREASING THE TORQUE REQUIRED TO FULLY ENGAGE THE SCREWS, AND THEREFORE STRIPPING THE BONE SCREW HEADS.

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). THESE PARTS ARE NOT APPROVED FOR USE IN THE UNITED STATES; HOWEVER, THE CATALOG # 9791223 AND 510K # K061274 OF 'LIKE DEVICES' WERE CLEARED IN THE UNITED STATES. DEVICES OF MULTIPLE PART/LOT NUMBERS WERE IMPLANTED DURING THE PROCEDURE INCLUDING: PART: G9791223 / LOT: H12V1686 PART: G9791223 / LOT: H13T3321 PART: G9791223 / LOT: H13B2280 ALTHOUGH IT IS UNKNOWN WHICH OF THESE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT DIAGNOSED WITH CERVICAL SPONDYLOTIC MYELOPATHY (CSM) UNDERWENT AN ACDF (ANTERIOR CERVICAL DISKECTOMY AND FUSION) AT C4-C6. IT WAS REPORTED THAT AFTER POSITIONING A THREAD PIN AND PLACING THE CERVICAL PLATE, THE SCREWS STRIPPED DURING INSERTION BEFORE THE PLATE LOCKING MECHANISM WAS ENGAGED. AWLING AND TAPPING WAS CONDUCTED AGAIN AT THE C6 LEFT SCREW AND A NEW 4.0X15MM SCREW WAS PLACED. THE PHYSICIAN ALSO REPLACED THE C5 LEFT SCREW BECAUSE IT REPORTEDLY STRIPPED AGAIN AFTER AWLING AND TAPPING. ADDITIONAL AWLING AND TAPPING WAS PERFORMED AND A 4.0X11MM SCREW WAS SUCCESSFULLY INSERTED EVENTUALLY. AFTER SCREW INSERTION, THE LOCKING MECHANISM WAS CONFIRMED TO BE PROPERLY FUNCTIONING. THE SURGICAL TIME WAS EXTENDED 16-30 MINUTES DUE TO THE INCIDENT. THE SURGEON COMMENTED THAT THE METAL STRENGTH SEEMED TO BE NOT HARD ENOUGH CONSIDERING THE SCREWS WERE STRIPPED SO EASILY. THE PHYSICIAN STATED THAT THE PATIENT HAD HARD BONE, BUT ALSO BELIEVED THAT THE METAL TENSILE STRENGTH OF THE SCREWS WAS NOT SUFFICIENT TO PREVENT STRIPPING. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313395 VENTURE ANTERIOR CERVICAL PLATE SYSTEM APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWP MEDTRONIC SOFAMOR DANEK PUERTO RICO OPERATIONS NA H12V1686

    Patients

    Seq Age Sex Outcome Treatment
    1 CORNERSTONE PEEK IMPLANT, PLATE