BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. RODS

    MDR report key: 24924655 · Received April 20, 2026

    Report

    Report Number
    3005180920-2026-00313
    Event Type
    Injury
    Date Received
    April 20, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 20, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030835346
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25 MARCH 2026. PEDICLE SCREW 03.50.401 ROD TI 5.5X200 (K121115) LOT 2226906: 50 ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2022. EXPIRATION DATE: 2027-11-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.50.401 ROD TI 5.5X200 (K121115) LOT 2220469: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MARCH-2022. EXPIRATION DATE: 2027-03-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.50.032 PEDICLE SCREW 7X50 (K121115) LOT 2458436: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-APR-2024. EXPIRATION DATE: 2029-03-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.50.032 PEDICLE SCREW 7X50 (K121115) LOT 2459089: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-APR-2024. EXPIRATION DATE: 2029-03-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. ROOT CAUSE:NO CASE-SPECIFIC INFORMATION WAS SUPPLIED; THEREFORE WE CANNOT MAKE A WELL-GROUNDED EVALUATION. NORMALLY, THESE EVENTS ARE CAUSED BY FATIGUE LOADING DUE TO THE UNEVEN DISTRIBUTION OF THE LOAD ALONG THE CONSTRUCT, RESULTING IN INCOMPLETE POST-OPERATIVE STABILIZATION, OR IN LACK OF FUSION - THE SCREWS AND RODS ARE TEMPORARY DEVICES, NOT DESIGNED TO SUSTAIN THE LOAD INDEFINITELY, SO IN CASE OF FAILURE OF FUSION, FATIGUE FRACTURES ARE ALMOST INEVITABLE. THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING-RELATED ISSUE OR SYSTEMIC DEFICIENCY.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO TWO RODS BREAKAGE (T12-S1) AND MOBILIZATION OF TWO PEDICLE SCREWS AT S1, AT ABOUT 1 YEAR 8 MONTHS AFTER THE PRIMARY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    987229 M.U.S.T. RODS ROD TI 5.5X200 KWP MEDACTA INTERNATIONAL SA 03.50.401 2220469 07630030835346

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention