BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM LOT. 1

    MDR report key: 9465003 · Received December 13, 2019

    Report

    Report Number
    3005180920-2019-01061
    Event Type
    Injury
    Date Received
    December 13, 2019
    Date of Event
    November 20, 2019
    Report Date
    December 13, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030857584
    PMA / PMN Number
    K141988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 02 DECEMBER 2019: LOT 1920189: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAR-2019. EXPIRATION DATE: 2024-02-18. 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. OTHER DEVICES INVOLVED IN THE EVENT: PEDICLE SCREW 03.52.323 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM LOT. 1621605 (K141988) BATCH REVIEW PERFORMED ON 02 DECEMBER 2019: LOT 1621605: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-SEPT-2017. EXPIRATION DATE: 2022-07-23. 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 03.52.321 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X30MM LOT. 1822721 (K141988). BATCH REVIEW PERFORMED ON 02 DECEMBER 2019: LOT 1822721: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19-DEC-2018. EXPIRATION DATE: 2023-12-06. 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. PEDICLE SCREW 03.52.322 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X35MM LOT. 1920767 (K141988). BATCH REVIEW PERFORMED ON XX DECEMBER 2019: LOT 1920767: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-MAR-2019. EXPIRATION DATE: 2024-03-12. 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 03.52.336 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X35MM LOT. 149086 (K141988). BATCH REVIEW PERFORMED ON 02 DECEMBER 2019: LOT 149086: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2015. EXPIRATION DATE: 2020-02-03. 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 03.52.336 ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 7X35MM LOT. 1621386 (K141988). BATCH REVIEW PERFORMED ON 02 DECEMBER 2019: LOT 1621386: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-MAR-2017. EXPIRATION DATE: 2022-02-15. 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 03.52.432 ENH. BENT ROD TI 5.5X80MM LOT. 1721266 (K141988). BATCH REVIEW PERFORMED ON 02 DECEMBER 2019: LOT 1721266: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-SEPT-2018. EXPIRATION DATE: 2023-09-17. 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.

    Description of Event or Problem · 1

    1 MONTH POST PRIMARY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE SET SCREWS AND ROD. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1263034 PEDICLE SCREW ENH. POLY-AXIAL PEDICLE SCREW - CANNULATED 6X40MM LOT. 1 PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 1920189 07630030857584

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention