BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X30MM

    MDR report key: 19307529 · Received May 14, 2024

    Report

    Report Number
    3005180920-2024-00309
    Event Type
    Injury
    Date Received
    May 14, 2024
    Date of Event
    April 15, 2024
    Report Date
    May 14, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030857560
    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 26-APR-2024: LOT 2023987: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-JAN-2021. EXPIRATION DATE: 2025-12-20. 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. ADDITIONAL IMPLANTS INVOLVED, BATCH REVIEW PERFORMED ON 26-APR-2024: PEDICLE SCREW 03.52.321 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X30MM (K141988) LOT 2124253: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2021. EXPIRATION DATE: 2026-08-22. 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 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM (K141988) LOT 2126410: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-DEC-2021. EXPIRATION DATE: 2026-11-15. 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 03.52.323 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM (K141988) LOT 2124566: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2021. EXPIRATION DATE: 2026-09-05. 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 03.52.324 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X45MM (K141988) LOT 2220280: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MAR-2022. EXPIRATION DATE: 2027-02-15. 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 03.52.324 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X45MM (K141988) LOT 2221117: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-MAR-2022. EXPIRATION DATE: 2027-02-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH TWO OTHER SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW (ALL THE IMPLANTS ARE INVOLVED IN THIS COMPLAINT). PEDICLE SCREW 03.52.440 ENH. BENT ROD TI 5.5X120MM (K141988) LOT 1620072C: (B)(4) ITEMS REWORKED AND RELEASED ON 25-JAN-2021. EXPIRATION DATE: 2026-01-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. PEDICLE SCREW 03.52.440 ENH. BENT ROD TI 5.5X120MM (K141988) LOT 2126706: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-FEB-2022. EXPIRATION DATE: 2027-01-19. 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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN REPORTING PAIN DUE TO LACK OF FUSION ON LEFT L5/S1. IT IS UNKNOWN WHY THIS OCCURRED. AT 1 YEAR AND 4 MONTHS POST PRIMARY THE SURGEON REMOVED ALL IMPLANTS AND REIMPLANTED NEW IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613386 PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X30MM SPINE PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 2023987 07630030857560

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention