BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAG/COM SCREW KIT 110/105

    MDR report key: 8465065 · Received March 29, 2019

    Report

    Report Number
    1020279-2019-01264
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    March 6, 2019
    Report Date
    April 23, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    UDI-DI
    03596010560551
    PMA / PMN Number
    K040212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE EXTRACTION OF THE LAG SCREW, THE STAFF DID NOT FOLLOW SURGICAL PROCEDURE AND USED THE INCORRECT ROD, SUBSEQUENTLY JAMMED IT IN THE LAG SCREW. THE CONNECTING ROD WAS CUT IN ORDER TO SALVAGE LAG SCREW WRENCH HANDLE. REP WAS CONTACTED AND STATED THAT HE WAS NOT EVEN SURE IF THE LAG SCREW WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258740 LAG/COM SCREW KIT 110/105 NAIL, FIXATION, BONE JDS SMITH & NEPHEW, INC. 18FT05268 03596010560551

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R