BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONSTER SCREW SYSTEM

    MDR report key: 16156608 · Received January 13, 2023

    Report

    Report Number
    3008650117-2023-00007
    Event Type
    Injury
    Date Received
    January 13, 2023
    Date of Event
    September 30, 2020
    Report Date
    January 13, 2023
    Manufacturer
    PARAGON 28, INC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    PER THE SURGICAL TECHNIQUE THIS IMPLANT PLACEMENT HAS NO IMPACT ON THE FUNCTION OF THE FHL TENDON. USER ERROR WAS IDENTIFIED ASSOCIATED EITHER WITH IMPLANT PLACEMENT OR INCORRECT SELECTION OF IMPLANT SIZE.

    Description of Event or Problem · 0

    3 MONTHS POSTOPERATIVELY THE PATIENT LOST FUNCTION OF THE FHL TENDON. REMOVAL OF THE AKIN OSTEOTOMY SCREW DID NOT RESTORE FHL FUNCTION. AFTER REMOVAL OF THIS SCREW THE TENDON WAS FOUND TO BE 90 PERCENT ATTENUATED AT THE LEVEL OF THE BASE OF THE PROXIMAL PHALANX/MTP JOINT. TENDON WAS REPAIRED WITH FRACTIONAL LENGTHENING.

    Description of Event or Problem · 0

    REVISION SURGERY CONDUCTED DUE TO LOSS OF FUNCTION OF FHL TENDON IDENTIFIED 3 MONTHS POST-OP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186117 MONSTER SCREW SYSTEM SCREW HWC PARAGON 28, INC P20-120-028S PA6976/56

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Required Intervention