BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEDICLE SCREW MUST LT 15MM SHORT - PEDICLE SCREW Ø4.5X30 CANN

    MDR report key: 18091488 · Received November 8, 2023

    Report

    Report Number
    3005180920-2023-00883
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    October 12, 2023
    Report Date
    December 11, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971278226
    PMA / PMN Number
    K203482
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICES RECEIVED ON 16 NOBEMBER 2023 AND ANALYZED BY MEDACTA SPINE R&D PROJECT MANAGER ON 21 NOVEMBER 2023: NO VISIBLE DEFECT CAN BE FOUND. THE MOST PROBABLE ROOT CAUSE FOR THE SCREW LOOSENING IS THE WEAKNESS OF THE PATIENT'S BONE.

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 31-OCT-2023. LOT 2227012: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-MAR-2023. EXPIRATION DATE: 2028-02-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 2 ITEMS IN THIS COMPLAINT. PEDICLE SCREW 03.57.003 MUST LT 15MM SHORT - PEDICLE SCREW Ø4.5X35 CANN (K203482) LOT: 2224911: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2022. EXPIRATION DATE: 2027-06-26. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 3 ITEMS IN THIS COMPLAINT. PEDICLE SCREW 03.57.003 MUST LT 15MM SHORT - PEDICLE SCREW Ø4.5X35 CANN (K203482) LOT 2222978: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2022. EXPIRATION DATE: 2027-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, NO ITEMS OF THE SAME LOT HAVE BEEN SOLD.

    Description of Event or Problem · 0

    ALL PEDICLE SCREWS LOOSENED DURING FINAL FIXATION OF SET SCREWS (T4-T7 FIXATION). ALL SCREWS WERE REPLACED WITH 30 MINUTES OF DELAY, 4 HOURS OF SURGERY. THE PATIENT BONE WAS WEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813026 PEDICLE SCREW MUST LT 15MM SHORT - PEDICLE SCREW Ø4.5X30 CANN PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 2227012 07630971278226

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male Other