BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW 03.58.225 MUST MC SCREW Ø5X45 CANNULATED

    MDR report key: 18191999 · Received November 22, 2023

    Report

    Report Number
    3005180920-2023-00915
    Event Type
    Injury
    Date Received
    November 22, 2023
    Date of Event
    October 23, 2023
    Report Date
    November 22, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971293373
    PMA / PMN Number
    K210427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 02 NOVEMBER 2023 LOT 2225728: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2022. EXPIRATION DATE: 2027-09-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ONLY ONE SCREW WAS INVOLVED BUT IT IS UNKNOWN WHICH ONE. HERE BELOW ALL THE SCREWS IMPLANTED DURING THE PRIMARY: PEDICLE SCREW 03.58.244 MUST MC SCREW Ø6X40 CANNULATED (K210427) LOT 2229875: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-FEB-2023. EXPIRATION DATE: 2028-01-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.58.245 MUST MC SCREW Ø6X45 CANNULATED (K210427) LOT 2222501: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUN-2022. EXPIRATION DATE: 2027-05-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH OTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. TWO DEVICES INVOLVED IN THIS EVENT. PEDICLE SCREW 03.58.243 MUST MC SCREW Ø6X35 CANNULATED (K210427) LOT 2222176: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2022. EXPIRATION DATE: 2027-05-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH OTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. TWO DEVICES INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    AT ABOUT 3 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND ONE OF THE SIX SCREWS WAS OBSERVED TO BE BROKEN AT THE BOTTOM OF THE CONSTRUCT. IT IS UNKNOWN HOW/WHY THIS OCCURRED. A REVISION SURGERY HAS NOT BEEN SCHEDULED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1668391 PEDICLE SCREW 03.58.225 MUST MC SCREW Ø5X45 CANNULATED SPINE SCREW CANNULATED NKB MEDACTA INTERNATIONAL SA 2225728 07630971293373

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention