BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUST LT 03.57.035 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 CANN

    MDR report key: 15824408 · Received November 18, 2022

    Report

    Report Number
    3005180920-2022-00844
    Event Type
    Injury
    Date Received
    November 18, 2022
    Date of Event
    October 6, 2022
    Report Date
    November 18, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971278462
    PMA / PMN Number
    K203482
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11-NOV-2022: LOT 2222997: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUL-2022. EXPIRATION DATE: 2027-06-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENT INVOLVED: BATCH REVIEW PERFORMED ON 11-NOV-2022: MUST LT 03.57.035 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 CANN (K203482) LOT 2222427: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-JUL-2022. EXPIRATION DATE: 2027-06-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. MUST LT 03.57.035 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 CANN (K203482) LOT 2220332: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-APR-2022. EXPIRATION DATE: 2027-02-20. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. MUST LT 03.57.035 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 CANN (K203482) LOT 2221910: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-MAY-2022. EXPIRATION DATE: 2027-05-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 1 MONTH AFTER THE PRIMARY SURGERY, A REVISION SURGERY WAS PERFORMED BECAUSE 4 OF THE 6 REPORTED SCREWS BACKED OUT. MOREOVER, DURING THE REVISION A SCREW WAS REPLACED WITH NEW ONE BUT IT WAS LOOSENED DURING ROD FIXATION. THE SCREW WAS REPLACED AGAIN AND A COMPLAINT WAS OPENED. THE SURGERY WAS ANYWAY COMPLETED SUCCESSFULLY WITHOUT CRITICAL DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229374 MUST LT 03.57.035 MUST LT 15MM SHORT - PEDICLE SCREW Ø7X45 CANN SPINE PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 03.57.035 2222997 07630971278462

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention