BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPHAEL

    MDR report key: 8011015 · Received October 26, 2018

    Report

    Report Number
    3009051471-2018-00012
    Event Type
    Malfunction
    Date Received
    October 26, 2018
    Date of Event
    February 27, 2018
    Report Date
    December 14, 2022
    Manufacturer
    CTL MEDICAL CORPORATION
    Product Code
    HWC
    Removal / Correction Number
    300905147108022018-001-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    DISTAL TIP OF A CANNULATED 5.5MM DIAMETER AND 45MM LENGTH PEDICLE SCREW WAS SPLAYED/PEELED/DEFORMED. THERE WAS NO MATERIAL SEPARATION OF THE IMPLANTABLE SCREW. DURING THE PEDICLE SCREW INSERTION PROCESS, THE SCREW WAS INITIALLY INSERTED, PARTIALLY REMOVED, AND FORCIBLY REINSERTED TO CHANGE SCREW INSERTION TRAJECTORY OVER INTERNALLY BENT K-WIRE INSIDE THE VERTEBRAL BODY. THIS RESULTED IN THE PLAYED/PEELED/DEFORMED DISTAL TIP OF THE PEDICLE SCREW. THE SUBJECT IMPLANT WAS THEN REMOVED AND REPLACED WITH ANOTHER SCREW. NO IMAGES PRE-OPERATION AND POST-OPERATIONAL IMAGES WERE PROVIDED. NO ADDITIONAL INFORMATION REGARDING SURGICAL TECHNIQUE WAS PROVIDED. NO HARM NOR INJURY WAS REPORTED TO THE PATIENT, SURGERY WAS COMPLETED WITH NEW IMPLANT. IN-HOUSE FAILURE MODE TESTING WAS COMPLETED TO REPLICATE THE INCIDENT. RESULTS DETERMINED THAT THIS FAILURE MODE OCCURED WHEN THE SCREW WAS ADVANCED DOWN A BENT TRAJECTORY CAUSING THE SCREW TO JAM IN THE BONE. ADDITIONAL ADVANCEMENT DOWN THE BENT TRAJECTORY WOULD RESULT IS SCREW TIP DEFORMATION AND SHEARING. WITHOUT FURTHER INFORMATION BEING PROVIDED OVER SURGCAL TECHNIQUE USED, THE CASE IS DEEMED INDETERMINATE. STRONG INDICATORS OF USER ERROR DUE TO DEVIATION FROM STANDARD SURGICAL TECHNIQUE WHERE K-WIRES SHOULD BE KEPT STRAIGHT FOR SCREW ADVANCEMENT. PREVIOUS SUBMISSION UNDER THE SAME NAME WAS COMPLETED (3009051471-2018-00012) - ADDITIONAL AND MORE SUFFICIENT INFORMATION IS BEING PROVIDED FOR REVIEW.

    Additional Manufacturer Narrative · 1

    DEVICES WERE RECALLED FOLLOWING A COMPLAINT ON THE HEX DRIVER MISSING THE RETENTION RING. OUT OF ALL THE RECALLED DEVICES, THE LOT 7EQBB-C HAD 6 DEVICE MALFUNCTION. RETENTION RINGS FOR THE 6 DEVICES WERE FOUND MISSING. AFTER CORRESPONDENCE WITH THE FDA, 6 DIFFERENT MDRS ARE BEING FILED FOR THE 6 DEVICES THAT MALFUNCTIONED IN THE LOT. THIS IS THE #3 REPORT # (B)(4).

    Description of Event or Problem · 1

    PARTS WERE RETURNED FROM SITE AND WERE MISSING THE RETENTION RING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851030 RAPHAEL PEDICLE SCREW HWC CTL MEDICAL CORPORATION 015.4647 8ANCB1
    851031 RAPHAEL PEDICLE SCREW HWC CTL MEDICAL CORPORATION 015.4647 8ANCB1

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown