BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M.U.S.T. PEDICLE SCREW 7X45

    MDR report key: 6266443 · Received January 20, 2017

    Report

    Report Number
    3005180920-2016-00754
    Event Type
    Injury
    Date Received
    January 20, 2017
    Date of Event
    December 21, 2016
    Report Date
    January 20, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MNI
    PMA / PMN Number
    K121115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO PEDICLE SCREWS AND 2 CAGES (SAME SIZES) WERE IMPLANTED DURING PRIMARY. TO DATE, IT IS UNKNOWN WHICH ONE OF THEM HAS BEEN EXPLANTED, FOR BOTH PEDICLE SCREW AND CAGE. ON (B)(6) 2017 THE (B)(6) MANAGER PERFORMED A PRELIMINARY INVESTIGATION AND COMMENTED AS FOLLOWS: REVISION SURGERY. THE SURGEON REPLACED ONE OF AT LEAST 4 SCREWS PREVIOUSLY IMPLANTED, AND THE INTERBODY CAGE. THIS MANEUVER CAN BE NECESSARY IN CASE OF PEDICLE FRACTURE OR PEDICLE SCREW LOOSENING. PEDICLE FRACTURE AND PEDICLE SCREW LOOSENING ARE WELL KNOWN COMPLICATIONS IN POSTERIOR SPINAL INSTRUMENTATION SURGERIES WITH OR WITHOUT ANTERIOR CAGE SUPPORT. MEANS THAT THE EVENT REPORTED IS A KNOWN COMPLICATION WITH THESE TYPES OF PATHOLOGIES TREATED WITH POSTERIOR INSTRUMENTATION. NO DIRECT RELATIONSHIP TO THE MEDACTA IMPLANTS CAN BE FORESEEN. BATCH REVIEWS PERFORMED ON 20 JANUARY 2017. PEDICLE SCREW 7X45, CODE 03.50.031, LOT. 155066 (K121115). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 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. PEDICLE SCREW 7X45, CODE 03.50.031, LOT. 156699 (K121115). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23 NOVEMBER 2015. EXPIRATION DATE: 2020-10-19. 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 INTERBODY FUSION DEVICE PEEK/TI 11X25X10 L10°, CODE 03.27.048, LOT. 143958 (K133192). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 FEBRUARY 2015. EXPIRATION DATE: 2020-01-31. 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 INTERBODY FUSION DEVICE PEEK/TI 11X25X10 L10°, CODE 03.27.048, LOT. 153234 (K133192). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 SEPTEMBER 2015. EXPIRATION DATE: 2020-07-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 54 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. PEDICLE SCREW BENT ROD TI 5.5X35MM, CODE 03.50.450, LOT. 142266 (K121115). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 NOVEMBER 2014. EXPIRATION DATE: 2019-11-04. 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 FRACTURED AT L5, AND WAS HAVING PAIN AND WEAKNESS. THE SURGEON REMOVED ONE INTERBODY 7X45MM PEDICLE SCREW, ONE CAGE AND TWO RODS. X-RAYS AND EXPLANTS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50980 M.U.S.T. PEDICLE SCREW 7X45 PEDICLE SCREW MNI MEDACTA INTERNATIONAL SA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention