BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 3894654 · Received June 25, 2014

    Report

    Report Number
    2520274-2014-12162
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    May 29, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR 5 LOCKING 5.0 SCREWS, PART AND LOT NUMBER UNKNOWN. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 A REPAIR/STABILIZATION WAS PERFORMED DUE TO A NON-UNION OF THE DISTAL FEMUR. THE ORIGINAL IMPLANT WAS PERFORMED (B)(6) 2013 IT WAS REPORTED A LATERAL VARIABLE ANGLE DISTAL FEMUR PLATE AND A MEDIAL 3.5MM LCP SMALL FRAGMENT PLATE WERE IMPLANTED. DURING THE REVISION ON (B)(6) 2014 THE SURGEON COMPLETELY REMOVED THE MEDIAL 3.5MM LCP PLATE AND SCREW CONSTRUCT. THE LATERAL PLATE REMAINED IN PLACE WITH ONLY THE PROXIMAL SCREWS, PROXIMAL TO THE NONUNION, BEING REMOVED. THE NONUNION SITE WAS TAKEN DOWN TO A BETTER BONY CONSTRUCT. THE SURGEON OSTEOTOMIZED AND SHORTENED THE FEMUR, THEN THE PROXIMAL SCREWS ON THE LATERAL PLATE WERE REPLACED WITH NEW SCREWS AND A NEW PLATE WAS PLACED ON THE MEDIAL ASPECT OF THE DISTAL FEMUR. THE LATERAL PLATE REMAINED IMPLANTED. NO PATIENT HARM WAS REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY. NO X-RAYS AVAILABLE. THIS REPORT IS FOR 5 LOCKING 5.0 SCREWS, PART AND LOT NUMBER UNKNOWN. THIS IS REPORT 4 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371726 SCREW, FIXATION, BONE HWC SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention