BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUST PEDICLE SCREW 8X40MM

    MDR report key: 7052116 · Received November 22, 2017

    Report

    Report Number
    3005180920-2017-00688
    Event Type
    Injury
    Date Received
    November 22, 2017
    Date of Event
    October 23, 2017
    Report Date
    November 22, 2017
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    NKB
    UDI-DI
    07630030834417
    PMA / PMN Number
    K132878
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEWS PERFORMED ON 20 NOVEMBER 2017. LOT 160534: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07 MARCH 2016. EXPIRATION DATE: 2021-02-15. 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. MUST PEDICLE SCREW 7X50MM, CODE 03.50.032, LOT. 160531 (K121115). (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11 MARCH 2016. EXPIRATION DATE: 2021-02-01. 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. MUST PEDICLE SCREW 7X45MM, CODE 03.50.031, LOT. 165548 (K121115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28 NOVEMBER 2016. EXPIRATION DATE: 2021-11-06. 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. MUST PEDICLE SCREW 7X50MM, CODE 03.50.032, LOT. 161898 (K121115) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30 MAY 2016. EXPIRATION DATE: 2021-04-06. 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. MUST PEDICLE SCREW 8X40MM, CODE 03.50.054, LOT. 153403 (K132878) (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JULY 2017. EXPIRATION DATE: 2020-06-03. 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.

    Description of Event or Problem · 1

    THE PATIENT HAD A PRIMARY FUSION OF L3-S1. THE PATIENT CAME IN COMPLAINING OF RIGHT LEG PAIN AND LOWER BACK PAIN. THE PATIENT PRESENTED WITH PSEUDO ARTHRITIS. THE SURGEON DETERMINED THAT THE SCREWS BACKED OUT. THE SURGEON REVISED ALL MEDACTA SCREWS AND RODS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    833133 MUST PEDICLE SCREW 8X40MM PEDICLE SCREW NKB MEDACTA INTERNATIONAL SA 160534 07630030834417

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention