BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEDICLE SCREW 5X45

    MDR report key: 7365118 · Received March 23, 2018

    Report

    Report Number
    3005180920-2018-00178
    Event Type
    Injury
    Date Received
    March 23, 2018
    Date of Event
    February 23, 2018
    Report Date
    March 23, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KWP
    UDI-DI
    07630030834158
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 22 MARCH 2018 BY THE SALES REPRESENTATIVE: SURGEON REPORTED THAT THE REMOVAL WAS ABSOLUTELY PERFORMED DUE TO INFECTION. HE SAW NO IMPLANT FAILURE 16 SCREWS WERE EXPLANTED , 1 OUT OF THE 17 LISTED IN THE COMPLAINT WAS NEVER IMPLANTED BUT TO DATE WE DO NOT KNOW WHICH IS. BATCH REVIEW PERFORMED ON 21 MARCH 2018: PEDICLE SCREW 5X45 REFERENCE 03.50.012; LOT 147632: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 NOVEMBER 2014. EXPIRATION DATE: 2019-11-10. 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 5X40 REFERENCE 03.50.011 (K121115); LOT 153394: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JULY 2015. EXPIRATION DATE: 2020-05-20. 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 4.5X30 REFERENCE 03.50.003 (K121115); LOT 152312: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03 JUNE 2015. EXPIRATION DATE: 2020-04-26. 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 6X45 REFERENCE 03.50.018 (K121115); LOT 155052: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 SEPTEMBER 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 (3 PIECES OF THE SAME LOT INVOLVED IN THIS CASE). PEDICLE SCREW 5X45 REFERENCE 03.50.012 (K121115); LOT 153389: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 JUNE 2015. EXPIRATION DATE: 2020-05-18 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 4.5X40 REFERENCE 03.50.005 (K121115); LOT 148279: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09 JANUARY 2015. EXPIRATION DATE: 12-10-2019. 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 4.5X35 REFERENCE 03.50.004 (K121115); LOT 152120: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13 APRIL 2015. EXPIRATION DATE: 2020-03-10. 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 4.5X35 REFERENCE 03.50.004 (K121115); LOT 125161: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 AUGUST 2013. EXPIRATION DATE: 10-31-2017. 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 4.5X35 REFERENCE 03.50.004 (K121115); LOT 124468: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 OCTOBER 2012. EXPIRATION DATE: 09-30-2017. 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 6X45 REFERENCE 03.50.018 (K121115); LOT 160524: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 FEBRUARY 2016. EXPIRATION DATE: 01-18-2021. 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

    REVISION SURGERY PERFORMED DUE TO SIGNS OF INFECTION ABOUT 1 YEAR AFTER PRIMARY. THE SURGEON REMOVED ALL MEDACTA HARDWARE. THE SURGEON PLANS TO IMPLANT ANOTHER COMPANY'S PRODUCT UPON THE INFECTION CLEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208470 PEDICLE SCREW 5X45 PEDICLE SCREW KWP MEDACTA INTERNATIONAL SA 147632 07630030834158

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention