BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2520274-2013-04686

    MDR report key: 3243312 · Received July 23, 2013

    Report

    Report Number
    2520274-2013-04686
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 24, 2013
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND A CATALOG NUMBER AND A LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT WAS IMPLANTED WITH A PLATE AND SCREW CONSTRUCT ON AN UNKNOWN DATE FOR A DISTAL RADIUS FRACTURE. PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2013 FOR REMOVAL OF A PLATE AND SCREWS. THE REASON FOR REMOVAL IS UNKNOWN. WHILE REMOVING THE VA-TCP PLATE, THE SURGEON TRIED TO ROTATE TWO VA SCREWS IN THE DISTAL ULNAR HOLES. REPORTEDLY, THE SURGEON DID NOT FEEL ANY RESISTANCE AND THE HEAD PARTS WERE REMOVED ONLY. AS THERE WAS NO SOUND OR RESISTANCE DURING THE PROCEDURE, THE SCREWS MAY HAVE ALREADY BEEN BROKEN. THE RESIDUAL SHAFT PARTS WERE REMOVED WITH FORCEPS, AND THERE WAS NO EVIDENCE OF RESIDUE IN THE PATIENTS BODY. THIS IS 3 OF 3 REPORTS FOR THE SAME EVENT, COMPLAINT # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343048 HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention