BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW MONOAXIAL SCREW 5X40MM

    MDR report key: 8979017 · Received September 10, 2019

    Report

    Report Number
    3005180920-2019-00763
    Event Type
    Injury
    Date Received
    September 10, 2019
    Date of Event
    August 14, 2019
    Report Date
    September 10, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030834981
    PMA / PMN Number
    K132878
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE REPORTER WAS NOT SURE ABOUT WHICH WAS THE CORRECT LOT OF THE EXPLANTED SCREW, WE PERFORMED A BATCH REVIEW FOR EACH LOT OF THE SCREW THAT WERE IMPLANTED DURING PRIMARY SURGERY: BATCH REVIEW PERFORMED ON 09 SEPT 2019- LOT 152470: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-SEP-2015. EXPIRATION DATE: 2020-08-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PEDICLE SCREW 03.50.222 MONOAXIAL SCREW 4.5X35MM (K132878), LOT. 152464. BATCH REVIEW PERFORMED ON 09 SEP 2019- LOT 152464: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2015. EXPIRATION DATE: 2020-11-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PEDICLE SCREW 03.50.253 MONOAXIAL SCREW 7X40MM (K132878), LOT. 152481. BATCH REVIEW PERFORMED ON 9 SEP 2019- LOT 152481: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-NOV-2015. EXPIRATION DATE: 2020-10-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PEDICLE SCREW 03.50.255 MONOAXIAL SCREW 7X50MM (K132878), LOT. 152483. BATCH REVIEW PERFORMED ON 09 SEP 2019- LOT 152483: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-NOV-2015. EXPIRATION DATE: 2020-10-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PEDICLE SCREW 03.50.232 MONOAXIAL SCREW 5X35MM (K132878), LOT. 152469. BATCH REVIEW PERFORMED ON 09 SEP 2019- LOT 152469: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-SEP-2015. EXPIRATION DATE: 2020-08-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PEDICLE SCREW 03.50.254 MONOAXIAL SCREW 7X45MM (K132878), LOT. 152482. BATCH REVIEW PERFORMED ON 09 SEP 2019- LOT 152482: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-NOV-2015. EXPIRATION DATE: 2020-10-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT PEDICLE SCREW 03.50.243 MONOAXIAL SCREW 6X40MM (K132878), LOT. 152475. BATCH REVIEW PERFORMED ON 09 SEP 2019- LOT 152475: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-NOV-2015. EXPIRATION DATE: 2020-10-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 5 DAYS AFTER PRIMARY SURGERY, COMPLAINING OF BILATERAL KNEE NUMBNESS. THE SURGEON REVISED ONE BROKEN PEDICLE SCREW.. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    773955 PEDICLE SCREW MONOAXIAL SCREW 5X40MM PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 152470 07630030834981

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention