BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4131169 · Received October 1, 2014

    Report

    Report Number
    2520274-2014-13861
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 3, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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

    IT WAS REPORTED A REMOVAL OF THE DISTAL RADIUS PLATE DUE TO BAD PLACEMENT OF THE HARDWARE OCCURRED. HARDWARE WAS IMPLANTED ABOUT A YEAR AGO, DATE UNKNOWN. THE FRACTURE WAS HEALED, BUT THE PATIENT HAD A TENDON DISRUPTION (RUPTURE) DUE TO THE BAD PLACEMENT. THE PLATE WAS REMOVED WITHOUT ANY ISSUES. THE PLATE WAS REMOVED SO THAT THE TENDON COULD BE REPAIRED. THE PATIENT STATUS OUTCOME WAS REPORTED AS GOOD AND THE PROCEDURE WAS REPORTED TO BE SUCCESSFULLY COMPLETED. NO DELAYS WERE REPORTED THIS REPORT IS FOR 5 UNKNOWN VARIABLE ANGLE LOCKING SCREWS THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612211 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention