BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE FREE GLIDING SCFE SCREW SYSTEM

    MDR report key: 15304925 · Received August 26, 2022

    Report

    Report Number
    3000327445-2022-00003
    Event Type
    Malfunction
    Date Received
    August 26, 2022
    Date of Event
    July 29, 2022
    Report Date
    August 26, 2022
    Manufacturer
    PEGA MEDICAL INC
    Product Code
    HWC
    UDI-DI
    07540194002266
    PMA / PMN Number
    K041393
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SCF-M73-L WAS MISTAKENLY PUT IN A BOX LABELED FOR AN SCF-T65-48S/50L DURING THE PREPARATION OF THE CUSTOMER ORDER.

    Description of Event or Problem · 0

    DURING THE REPLENISHMENT OF A TRAY BY THE DISTRIBUTOR, THE BOX LABELED FOR A SCF-T65-48S/50L COMPONENT WAS FOUND WITH A SCF- M73-L COMPONENT INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067092 THE FREE GLIDING SCFE SCREW SYSTEM MINI FEMALE COMPONENT 48/50MM, Ø6.5MM HWC PEGA MEDICAL INC SCF-T65-48S/50L B103-07 07540194002266

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown