BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINE INSTRUMENTS

    MDR report key: 23591140 · Received November 19, 2025

    Report

    Report Number
    3005180920-2025-01108
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 1, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LXH
    UDI-DI
    07630971202542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 27 OCTOBER 2025: LOT 1952060: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-DEC-2019. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 4 SIMILAR EVENTS HAVE BEEN REPORTED ON THE SAME LOT DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.52.323 ENH. CANN. PEDICLE SCREW 6X40MM + NUT (1X) STERILE (K141988) LOT 2328427: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 29-NOV-2023. EXPIRATION DATE: 2028-NOV-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. VISUAL INSPECTION PERFORMED BY MEDACTA SPINE R&D PROJECT MANAGER: PEDICLE SCREWDRIVER BROKE ON THE TORX T20 INTERFACE WITH THE SCREW, WITH A 45° ANGLE, SIGN OF EXCESSIVE TORQUE APPLIED. FOR THE PEDICLE SCREWDRIVER, BREAKAGE CAN OCCUR IN CASE OF HIGH INSERTION TORQUE, TYPICALLY RELATED TO LARGE DIAMETER SCREWS (MORE THAN 7MM), LONG SCREWS (MORE THAN 60MM), AND/OR HARD BONE (E.G. SACRAL BONE, SCLEROTIC BONE). IN THIS CASE: SCREW SIZE: Ø6X40; TAPPING: YES; BONE QUALITY: GOOD; LEVEL: L4-L5. THE INSTRUMENT SET INCLUDES TWO SCREWDRIVERS AND ANOTHER SCREWDRIVER TO COMPLETE THE SURGERY IN CASE OF BREAKAGE. THE STRENGTH OF THE TIP OF THE SCREWDRIVER IS DETERMINED BY THE DIMENSION OF THE INTERFACE (HEXALOBE T20) AND THE MATERIAL (AISI 420 MOD), WHICH ARE COMPARABLE TO PREDICATE DEVICES. GEOMETRICAL FEATURES ARE DRIVEN BY THE IMPLANT DESIGN AND ARE EQUIVALENT TO SIMILAR PRODUCTS IN THE MARKET. THE MATERIAL IS AMONG THE STRONGEST FOR SUCH APPLICATIONS IN TERMS OF STRENGTH AND HARDNESS. THE SCREW PRESENT THE TORX WITH SIGN OF DEFORMATION, PROBABLY CAUSED BY THE BREAKAGE OF THE SCREWDRIVER. CONCLUSIONS: BREAKAGE OF THE TIPS MAY HAVE OCCURRED DUE TO HIGH INSERTION TORQUE RESULTING FROM THE COMBINED FACTORS OF SCREW DIAMETER, HARD/SCLEROTIC BONE CONDITION, AND THE SPECIFIC CONDITIONS OF THE SCREW HOLE PREPARATION, IN COMBINATION WITH THE INHERENT MECHANICAL LIMITS OF THE DEVICES INVOLVED. THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIALLY RELATED MANUFACTURING ISSUE.

    Description of Event or Problem · 0

    DURING SPINAL MIS SURGERY, THE TIP OF A SCREWDRIVER BROKE WHILE IMPLANTING THE THIRD PEDICLE SCREW (SURGICAL TECNIQUE FOLLOWED, AWL, WIRE AND TAP USED), CAUSING SLIGHT DAMAGE TO THE SCREW TULIP AND MAKING THE INSTRUMENT UNUSABLE. THE SURGERY WAS NOT AFFECTED, AS A SPARE SCREWDRIVER WAS AVAILABLE, AND NO HARM OCCURRED TO THE PATIENT. THE OPERATED LEVELS WERE L4-L5. THE PATIENT'S BONE QUALITY WAS GOOD, WITH NO SIGNS OF OSTEOPOROSIS OR ABNORMAL DENSITY. A NEW SCREW (SIZE UNKNOWN) WAS OPENED AND USED BECAUSE THE DAMAGED SCREW SHOWED MINOR DENTING, EVEN THOUGH NO FRAGMENT REMAINED ATTACHED TO THE IMPLANT. THE SURGEON PERFORMED A MINI-OPEN APPROACH (CUT EXTENSION), USED A PEDICLE AWL AND PEDICLE PROBE LUMBAR, TO POSITION THE NEW SCREW. NO PART OF THE INSTRUMENT REMAINED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2882355 SPINE INSTRUMENTS MUST PEDICLE SCREWDRIVER - MIS HYBRID LXH MEDACTA INTERNATIONAL SA 03.52.10.0406 1952060 07630971202542

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other