BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP(TM) DISTAL FEMUR PLATE 13 HOLES/316MM-RIGHT

    MDR report key: 9835350 · Received March 16, 2020

    Report

    Report Number
    8030965-2020-01952
    Event Type
    Injury
    Date Received
    March 16, 2020
    Report Date
    February 18, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819189164
    PMA / PMN Number
    K062564
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/ INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/ OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). 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

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018 THAT A REVISION PROCEDURE WAS PERFORMED TO REMOVE A BROKEN PLATE DUE TO A NON UNION AND IMPLANT FAILURE. THIS REVISION REMOVED A BROKEN PLATE, REDUCED THE FRACTURE ANATOMICALLY AS BEST AS THEY COULD AND ADDED A BONE GRAFT. THE SURGEON MENTIONED THAT THE PATIENT MAY HAVE A METABOLIC DISORDER AND OTHER CO MORBIDITIES. THE SURGEON DOES NOT FEEL THE PLATE CONTRIBUTED TO ANY OF THE REVISIONS. HE FELT THAT THE PRIMARY PLATE FAILED DUE TO POOR REDUCTION AND OVER BENDING PLATE. THE REVISION SURGEON BELIEVED THAT THE ORIGINAL PLATE MAY HAVE BEEN BENT PAST EXCESSIVELY AND REDUCTION WAS NOT ANATOMICAL. CONCOMITANT DEVICES: 5.0MM LOCKING SCREWSELF-TAPPING 80MM (PRODUCT CODE: 213.380, LOT #: L528658, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 75MM (PRODUCT CODE: 213.375, LOT #: 7918910, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 75MM (PRODUCT CODE: 213.375, LOT #: L108563, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 65MM (PRODUCT CODE: 213.365, LOT #: 2161126, QUANTITY: 2), 5.0MM LOCKING SCREW SELF-TAPPING 55MM (PRODUCT CODE: 213.355, LOT #: 9875351, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 40MM (PRODUCT CODE: 213.340, LOT #: L629099, QUANTITY: 1), 4.5MM CORTEX SCREW SELF-TAPPING 36MM (PRODUCT CODE: 214.836, LOT #: 9401022, QUANTITY: 1). THIS REPORT IS FOR ONE LCP(TM) DISTAL FEMUR PLATE 13 HOLES/ 316MM-RIGHT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297361 LCP(TM) DISTAL FEMUR PLATE 13 HOLES/316MM-RIGHT PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH L421628 07611819189164

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention