BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 4220030 · Received November 3, 2014

    Report

    Report Number
    2520274-2014-14455
    Event Type
    Injury
    Date Received
    November 3, 2014
    Report Date
    February 14, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR 8 UNKNOWN SCREWS. THE FOLLOWING PARTS AND LOT NUMBERS WERE PROVIDED, BUT IT IS NOT CLEAR WHICH OR HOW MANY SCREWS WERE LOOSE: 204.822 - 8053117, 212.108 - 7969942 212.107 - 8112713, 212.108 - 8259512 X 2, 212.105 - 8034116, 212.107 - 8265884, 212.107 - 7969946, WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT HAD A NON-UNION OCCUR. THE LOCKING COMPRESSION PLATE WAS RELEASED FROM THE BONE. PROCEDURE WAS PERFORMED ON (B)(6) 2014 TO REMOVE A PLATE, AND EIGHT SCREWS. A NEW PLATE WAS USED; SURGERY WAS COMPLETED SUCCESSFULLY WITH NO REPORTED DELAY AND NO HARM TO THE PATIENT. THIS REPORT IS FOR EIGHT UNKNOWN SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704020 SCREW,FIXATION,BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention