BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP CONDYLAR PLATE 12 HOLES/278MM-RIGHT

    MDR report key: 1900111 · Received November 10, 2010

    Report

    Report Number
    1719045-2010-00327
    Event Type
    Injury
    Date Received
    November 10, 2010
    Date of Event
    October 10, 2010
    Report Date
    October 11, 2010
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HRS
    PMA / PMN Number
    K000066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT EXPLANTED. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED OR LOT NUMBER PROVIDED. SYNTHES IS UNABLE TO DETERMINE MANUFACTURING DATE WITHOUT A LOT NUMBER.

    Description of Event or Problem · 1

    PT REPORTED FEELING THE 4.5MM LCP CONDYLAR PLATE BREAK ON (B)(6) 2010. X-RAYS CONFIRMED THE POSTOP PLATE BREAKAGE. THE PLATE WAS IMPLANTED ON (B)(6) 2009, FOR NON-UNION OF A SUPRA CONDYLAR FEMUR FRACTURE. PT WAS ORIGINALLY IMPLANTED WITH A LOCKING CONDYLAR DISTAL FEMUR PLATE WHICH BROKE AFTER APPROXIMATELY EIGHT MONTHS TO ONE YEAR. THE PLATE WAS REMOVED AND PT WAS REVISED (B)(6) 2009. SURGEON IS CONSIDERING A THIRD SURGERY TO REVISE THE PT OR SENDING THE PT TO A TRAUMATOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4.5MM LCP CONDYLAR PLATE 12 HOLES/278MM-RIGHT LCP CONDYLAR PLATE HRS SYNTHES MONUMENT NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Required Intervention SCREWS