BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM

    MDR report key: 18191989 · Received November 22, 2023

    Report

    Report Number
    3005180920-2023-00916
    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
    07630030857577
    PMA / PMN Number
    K141988
    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 2122647: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUL-2021. EXPIRATION DATE: 2026-06-11. 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: BATCH REVIEW PERFORMED ON 02 NOVEMBER 2023 ON PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL. PEDICLE SCREW - CANNULATED 6X35MM (K141988) LOT. 2123664. LOT 2123664: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEPT-2021. EXPIRATION DATE: 2026-09-01. 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. BATCH REVIEW PERFORMED ON 02 NOVEMBER 2023 ON PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM (K141988) LOT. 2227714 LOT 2227714: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2022. EXPIRATION DATE: 2027-11-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. TWO DEVICES INVOLVED IN THIS EVENT. BATCH REVIEW PERFORMED ON 02 NOVEMBER 2023 ON PEDICLE SCREW 03.52.323 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM (K141988) LOT. 2227715. LOT 2227715: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-NOV-2022. EXPIRATION DATE: 2027-11-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. TWO DEVICES INVOLVED IN THIS EVENT.

    Description of Event or Problem · 0

    AT 6 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
    1925499 PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM SPINE POLYAXIAL PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 2122647 07630030857577

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention