BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP® CONDYLAR PLATE 8 HOLES/206MM-LEFT

    MDR report key: 3220873 · Received July 11, 2013

    Report

    Report Number
    3003506883-2013-00296
    Event Type
    Injury
    Date Received
    July 11, 2013
    Report Date
    June 20, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K000066
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REVIEW OF THE RESPECTIVE RAW MATERIAL, COMPONENT, AND FINISHED PRODUCT DHR FILES FOUND NO IRREGULARITIES THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS CONDITION. BASED ON THIS INFORMATION ALONE, THIS COMPLAINT IS DEEMED INVALID.

    Additional Manufacturer Narrative · 1

    PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCREWS AND PLATE WERE IMPLANTED TO REPAIR A LEFT FEMORAL FRACTURE ON AN UNKNOWN DATE. THE DEVICES WERE DAMAGED AT AN UNKNOWN TIME. AN X-RAY REVEALED TWO SCREWS WERE BROKEN AND THE PLATE WAS BENT. THE PLATE AND SCREWS WERE REPLACED WITH A ROD ELECTRO GRADE TO STABILIZE THE FRACTURE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320232 4.5MM LCP® CONDYLAR PLATE 8 HOLES/206MM-LEFT HRS SYNTHES ELMIRA 5368220

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention