BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP® POSTEROLATERAL DISTAL HUMERUS PLATE 3H-LEFT

    MDR report key: 3952924 · Received July 23, 2014

    Report

    Report Number
    3006126083-2014-10015
    Event Type
    Injury
    Date Received
    July 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    SYNTHES RARON
    Product Code
    KTT
    PMA / PMN Number
    PK033995
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    IT WAS REPORTED THAT THE PATIENT HAS PAIN DUE TO THE HARDWARE. A ROUTINE FOLLOW UP OF AN OPEN REDUCTION INTERNAL FIXATION OF THE LEFT DISTAL HUMERUS REVEALED THE DISTAL HUMERUS WAS COMPLETELY HEALED. ALL HARDWARE WAS INTACT AND THE DECISION WAS MADE TO REMOVE ALL THE HARDWARE. THERE WEREN¿T ANY PATIENT COMPLICATIONS WITH THE REMOVAL. THIS IS REPORT 8 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430283 3.5MM LCP® POSTEROLATERAL DISTAL HUMERUS PLATE 3H-LEFT APPLIANCE, FIXATION, NAIL KTT SYNTHES RARON 3829553

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention