BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM

    MDR report key: 3823334 · Received May 21, 2014

    Report

    Report Number
    2520274-2014-11562
    Event Type
    Injury
    Date Received
    May 21, 2014
    Report Date
    April 30, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    KTW
    PMA / PMN Number
    PK011815
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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 TWO LOCKING SCREWS ARE BACKING OUT OF A PROXIMAL HUMERAL OPEN REDUCTION AND INTERNAL FIXATION (ORIF) WITH A LOCKING PROXIMAL HUMERAL PLATE. THIS WAS DISCOVERED TWO WEEKS POSTOPERATIVELY THROUGH XRAY. THE DEVICE WAS REPORTED TO HAVE BEEN IMPLANTED ON (B)(6), 2014. THE FRACTURE IS TRANSLATING INTO A VARUS POSITION. PATIENT COMPLAINS OF PAIN. NO MEDICAL INTERVENTION SCHEDULED AT THIS TIME. PLAN TO WAIT AND SEE HOW PATIENT RESPONDS. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303900 3.5MM LCP® PROXIMAL HUMERUS PLATE-STANDARD 3H SHAFT/90MM APPLIANCE,FIXATION,NAIL/BLADE/PLATE COMBO, SINGLE COMPONENT KTW SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention