BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HRS ASSEMBLY SCREW

    MDR report key: 19986272 · Received August 14, 2024

    Report

    Report Number
    0001649390-2024-00367
    Event Type
    Injury
    Date Received
    August 14, 2024
    Date of Event
    June 1, 2024
    Report Date
    August 14, 2024
    Manufacturer
    TORNIER INC
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    PATIENT: (B)(6) - FLEX REVIVE STUDY. ADVERSE EVENT DETAIL: POST-OPERATIVE COMPLICATION: INCREASED PAIN AND STIFFNESS OF RIGHT SHOULDER. PATIENT HAS NO REDNESS OR SWELLING. ABNORMAL LABS (B)(6) 2024: CRP, ESR, CBC (HGB, HCT, RDW) AS WELL AS UNDERLYING DEGENERATIVE DISK DISEASE OF THE CERVICAL SPINE. TREATMENT/MEDICATION: PREDNISONE 5MG FOR 15 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1152851 UNKNOWN HRS ASSEMBLY SCREW PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS TORNIER INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention