BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF OBLIQUE (TI PEEK) TIPEEK 10X24X10 L5°

    MDR report key: 19605509 · Received June 25, 2024

    Report

    Report Number
    3005180920-2024-00443
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    May 23, 2024
    Report Date
    June 25, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630971290587
    PMA / PMN Number
    K212831
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 JUNE 2024: LOT 2122238: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-OCT-2021. EXPIRATION DATE: 2026-09-29. 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 DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 04 JUNE 2024: PEDICLE SCREW 03.52.455 ENH. BENT ROD TI R100 5.5X45MM (K141988) LOT 1620075B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-JUN-2022. EXPIRATION DATE: 2027-05-31. 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 03.52.456 ENH. BENT ROD TI R100 5.5X50MM (K141988) LOT 1620076B: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-DEC-2022. EXPIRATION DATE: 2027-12-01. 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. MUST LT 03.59.034 MUST LT 15MM LONG - PEDICLE SCREW Ø7X40 CANN (K203482) LOT 2022534: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-MARCH-2021. EXPIRATION DATE: 2026-02-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO OTHER SIMILAR REPORTED EVENTS DURING THE PERIOD OF REVIEW. (2 DEVICES INVOLVED IN THIS COMPLAINT)

    Description of Event or Problem · 0

    AT 9 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND THERE WAS A NON-UNION OF THE VERTEBRAS. THE SURGEON REMOVED ALL COMPONENTS EXCEPT THE Ø7X45 PEDICLE SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE BONE WAS OSTEOPOROTIC AND THE PATIENT WAS OVERALL UNHEALTHY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449075 MECTALIF OBLIQUE (TI PEEK) TIPEEK 10X24X10 L5° SPINE TIPEEK CAGE MAX MEDACTA INTERNATIONAL SA 2122238 07630971290587

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention