BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP® CONDYLAR PLATE 6 HOLES/170MM-LEFT

    MDR report key: 3320676 · Received August 31, 2013

    Report

    Report Number
    2520274-2013-05889
    Event Type
    Injury
    Date Received
    August 31, 2013
    Report Date
    August 8, 2013
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    PMA / PMN Number
    K000066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE FOR THIS REPORT INCLUDES HTY, JDW, AND HRS. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT SUSTAINED A DISTAL FEMUR NON-UNION WHICH RESULTED IN A BROKEN 4.5MM CONDYLAR LOCKING COMPRESSION PLATE. THE PATIENT UNDERWENT A SECOND SURGERY TO DEBRIDE THE NON-UNION AND RE-PLATE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433557 4.5MM LCP® CONDYLAR PLATE 6 HOLES/170MM-LEFT HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention