BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REFORM PEDICLE SCREW SYSTEM

    MDR report key: 12796827 · Received November 11, 2021

    Report

    Report Number
    3005739886-2021-00060
    Event Type
    Malfunction
    Date Received
    November 11, 2021
    Date of Event
    September 6, 2021
    Report Date
    October 18, 2021
    Manufacturer
    PRECISION SPINE, INC.
    Product Code
    HXX
    UDI-DI
    00840019928366
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    H3 DEVICE EVALUATION - THE DRIVER WAS EXAMINED WITH THE AID OF A 5X LOOP. THE TIP OF THE DRIVER IS MISSING. THE BREAK REGION CONSISTS OF A FRACTURE AREA THAT IS SKEWED RELATIVE TO THE DRIVER'S LONGITUDINAL AXIS. MULTIPLE FRACTURE PLANES ARE PRESENT WITH RATCHET MARKS AROUND THE DISTAL PERIPHERY. SHINY AREAS ARE ALSO PRESENT. BASED UPON THESE OBSERVATIONS IT IS BELIEVED THAT A CRACK MAY HAVE BEEN INITIATED AT SOME PRIOR POINT IN TIME. THE SHINY AREAS ARE BELIEVED TO BE DUE TO RUBBING AT THE CRACK INTERFACES. THE CAUSE FOR THE INITIAL FRACTURE IS BELIEVED TO BE DUE TO TORSION COMBINED WITH BENDING MOMENT APPLICATION. REVIEW OF DEVICE HISTORY RECORDS FOUND TWENTY (20) PIECES OF LOT 3333MM WERE RELEASED FOR DISTRIBUTION ON 5/21/2015 WITH NO DEVIATION OR ANOMALIES. TWO-YEAR COMPLAINT HISTORY REVIEW (10.18.2019-10.18.021) DID NOT REVEAL A TREND FOR REPORTS OF THIS NATURE FOR THIS PART NUMBER. NO CORRECTIVE ACTIONS ARE BEING RECOMMENDED AT THIS TIME. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 3005739886-2021-00059-1 / 00061-1).

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION - UNKNOWN. INITIAL REPORTER OCCUPATION - OTHER; DISTRIBUTOR. EVALUATION IN PROCESS BUT NOT YET COMPLETE. UPON COMPLETION OF EVALUATION, A FOLLOW UP REPORT WILL BE SUBMITTED. THIS REPORT IS NUMBER 2 OF 3 MDRS FILED FOR THE SAME EVENT (REFERENCE 3005739886-2021-00059 / 00061).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A THREE-LEVEL PROCEDURE WAS PERFORMED IN SAUDI ARABIA ON (B)(6) 2021, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. WHILE THE SURGEON WAS LOCKING THE LOCK SCREW THE TIPS OF TWO LOCK-SCREW TORQUE DRIVERS (39-RD-0060) BROKE. THE TIP OF A T20, RETENTION BONE-SCREW DRIVER, REFORM (39-SP-0601) ALSO BROKE. ALL BROKEN TIPS WERE REMOVED AND ALL LOCK SCREWS WERE SUCCESSFULLY TIGHTENED USING THE TORQUE LIMITING HANDLE. THERE WAS NO PATIENT INJURY OR DELAY TO THE PROCEDURE RESULTING FROM THESE FAILURES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A THREE-LEVEL PROCEDURE WAS PERFORMED IN (B)(6) ON (B)(6) 2021, UTILIZING THE REFORM PEDICLE SCREW SYSTEM. WHILE THE SURGEON WAS LOCKING THE LOCK SCREW THE TIPS OF TWO LOCK-SCREW TORQUE DRIVERS (39-RD-0060) BROKE. THE TIP OF A T20, RETENTION BONE-SCREW DRIVER, REFORM (39-SP-0601) ALSO BROKE. ALL BROKEN TIPS WERE REMOVED AND ALL LOCK SCREWS WERE SUCCESSFULLY TIGHTENED USING THE TORQUE LIMITING HANDLE. THERE WAS NO PATIENT INJURY OR DELAY TO THE PROCEDURE RESULTING FROM THESE FAILURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699792 REFORM PEDICLE SCREW SYSTEM SCREWDRIVER HXX PRECISION SPINE, INC. 39-RD-0060 3333MM 00840019928366

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown