BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUST LT 25MM LONG - PEDICLE SCREW Ø6X45 CANN

    MDR report key: 18543707 · Received January 19, 2024

    Report

    Report Number
    3005180920-2024-00004
    Event Type
    Injury
    Date Received
    January 19, 2024
    Date of Event
    January 2, 2024
    Report Date
    January 19, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630971279544
    PMA / PMN Number
    K203482
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN WHICH IS THE SCREW INVOLVED IN THE EVENT BATCH REVIEW PERFORMED ON 17 JANUARY 2024: PEDICLE SCREW 03.59.225 MUST LT 25MM LONG - PEDICLE SCREW Ø6X45 CANN (K203482) LOT. 2126530 LOT 2126530: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JUL-2022. EXPIRATION DATE: 2027-JUN-06. 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 03.59.225 MUST LT 25MM LONG - PEDICLE SCREW Ø6X45 CANN (K203482) LOT. 2221953 LOT 2221953: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUL-2022. EXPIRATION DATE: 2027-JUN-30. 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 03.59.225 MUST LT 25MM LONG - PEDICLE SCREW Ø6X45 CANN (K203482) LOT. 2225791 LOT 2225791: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-AUG-2022. EXPIRATION DATE: 2027-JUL-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. PEDICLE SCREW 03.59.225 MUST LT 25MM LONG - PEDICLE SCREW Ø6X45 CANN (K203482) LOT. 2228147 LOT 2228147: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-NOV-2022. EXPIRATION DATE: 2027-OCT-23. 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 03.59.235 MUST LT 25MM LONG - PEDICLE SCREW Ø7X45 CANN (K203482) LOT. 2225796 LOT 2225796: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-OCT-2022. EXPIRATION DATE: 2027-SEP-06. 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 03.59.235 MUST LT 25MM LONG - PEDICLE SCREW Ø7X45 CANN (K203482) LOT. 2228148 LOT 2228148: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-DEC-2022. EXPIRATION DATE: 2027-OCT-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.

    Description of Event or Problem · 0

    THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT A SET SCREW HAD POPPED OUT. ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON LOCKED DOWN THE ROD AND PUT IN A NEW SET SCREW. THE SURGERY WAS COMPLETED SUCCESSFULLY. TORQUE LIMITER USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2406910 MUST LT 25MM LONG - PEDICLE SCREW Ø6X45 CANN SPINE PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 2126530 07630971279544

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention