BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SKELETAL DYNAMICS

    MDR report key: 10282935 · Received July 16, 2020

    Report

    Report Number
    3006742481-2020-00005
    Event Type
    Injury
    Date Received
    July 16, 2020
    Date of Event
    March 20, 2020
    Report Date
    June 9, 2020
    Manufacturer
    SKELETAL DYNAMICS
    Product Code
    HWC
    UDI-DI
    00841506101286
    PMA / PMN Number
    K182492
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SYSTEM INSTRUCTIONS FOR USE WARNINGS STATE: FOR SAFE EFFECTIVE USE OF THE IMPLANT, THE SURGEON MUST BE THOROUGHLY FAMILIAR WITH THE SURGICAL TECHNIQUE FOR THE DEVICE, IMPLANT, AND ASSOCIATED INSTRUMENTS. AS PER OUR SURGERY USAGE CHARGE FORM RELATED WITH THIS CASE, REQUIREMENT FOR THE INSTRUMENT LISTED IN THE SURGICAL TECHNIQUE LABELED AS "SINGLE USE ONLY" WAS NOT MET. EVIDENCE SUGGESTS THAT THE INSTRUMENT HAS BEEN USED MULTIPLE TIMES. REUSING INSTRUMENTS LABELED "SINGLE USE ONLY" MAY COMPROMISE THE STRUCTURAL INTEGRITY OF THE INSTRUMENT.

    Description of Event or Problem · 1

    USER SUBMITTED A REPORT TO THE FDA STATING: DURING PLACEMENT OF A LOCKING SCREW, THE TIP OF A SCREWDRIVER BROKE FLUSH INTO THE HEAD OF X1 LOCKING SCREW. ATTEMPTS WERE MADE TO REMOVE THE BROKEN SCREWDRIVER TIP FROM THE HEAD OF THE LOCKING SCREW. THIS COULD NOT BE ACHIEVED AS THE TIP WAS INCARCERATED WITHIN THE HEAD OF THE LOCKING SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749785 SKELETAL DYNAMICS DRIVER, AO CONNECTION, POLYAXIAL LOCKING SCREW HWC SKELETAL DYNAMICS Driver, AO Connection, Polyaxial Locking Screw 00841506101286

    Patients

    Seq Age Sex Outcome Treatment
    1 Other