BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX30MM

    MDR report key: 8027620 · Received November 1, 2018

    Report

    Report Number
    1818910-2018-74129
    Event Type
    Injury
    Date Received
    November 1, 2018
    Report Date
    October 11, 2018
    Manufacturer
    DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655
    Product Code
    LPH
    UDI-DI
    10603295010159
    PMA / PMN Number
    K983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES LOOSENING OF CUP AFTER FIRST REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    867522 PINN CAN BONE SCREW 6.5MMX30MM BONE SCREWS AND PINS : SCREWS LPH DEPUY RAYNHAM, A DIV. OF DEPUY ORTHO 1219655 C99AX4000 10603295010159

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention