BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI

    MDR report key: 8159742 · Received December 13, 2018

    Report

    Report Number
    3005180920-2018-00992
    Event Type
    Injury
    Date Received
    December 13, 2018
    Date of Event
    November 13, 2018
    Report Date
    December 13, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MAX
    UDI-DI
    07630030831867
    PMA / PMN Number
    K133192
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 DECEMBER 2018. LOT 151364: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 MAY 2015. EXPIRATION DATE: 2020-05-05. 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. ADDITIONAL IMPLANTS INVOLVED: PEDICLE SCREW 03.50.457 BENT ROD TI 5.5X70MM, LOT 140593: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24 JUNE 2014 . EXPIRATION DATE: 2019-05-31. 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. MECTALIF POSTERIOR (TI PEEK) 03.27.025 POSTERIOR INTERBODY FUSION DEVICE PEEK/TI 11X25X9 L10°, LOT 143969: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 JANUARY 2015. EXPIRATION DATE: 2019-12-31. 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 03.50.030 PEDICLE SCREW 7X40, LOT 150647: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 FEBRUARY 2015. EXPIRATION DATE: 2020-01-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD. TWO PIECES OF THE SAME LOT INVOLVED IN THE CURRENT EVENT. PEDICLE SCREW 03.50.032 PEDICLE SCREW 7X50, LOT 141385: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25 MARCH 2014. EXPIRATION DATE: 2019-02-28. 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 03.50.032 PEDICLE SCREW 7X50, LOT 123758: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 SEPTEMBER 2012. EXPIRATION DATE: 2017-08-31. 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 03.50.054 PEDICLE SCREW 8X40MM, LOT 146265: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17 SEPTEMBER 2014. EXPIRATION DATE: 2019-07-31. 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 03.50.054 PEDICLE SCREW 8X40MM, LOT 148270: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 JANUARY 2014. EXPIRATION DATE: 2019-11-30. 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

    ON (B)(6) 2018 WE WERE INFORMED ABOUT A PATIENT WHO CAME IN COMPLAINING OF PAIN 3 YEARS AFTER PRIMARY. THE SURGEON PLANNED TO REVISE ALL MEDACTA HARDWARE WITH A COMPETITOR'S HARDWARE AND EXTEND THE FUSION TO ANOTHER LEVEL. ON (B)(6) 2018, THE AGENT REPORTED THAT THE CASE HAS BEEN RESCHEDULED DUE TO THE PATIENT BEING SICK AND THE REVISION DATE IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002403 MECTALIF POSTERIOR (TI PEEK) POSTERIOR INTERBODY FUSION DEVICE PEEK/TI SPINE INTERBODY FUSION DEVICE MAX MEDACTA INTERNATIONAL SA 151364 07630030831867

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention