BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNTHES

    MDR report key: 350413 · Received August 30, 2001

    Report

    Report Number
    MW1022769
    Event Type
    Injury
    Date Received
    August 30, 2001
    Date of Event
    April 26, 2001
    Report Date
    August 30, 2001
    Manufacturer
    SYNTHES
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD INTERNAL FIXATION OF CLAVICLE WITH A SYNTHES 345 RECON PLATE - 8 HOLE, 3.5 MM - IN 2000. INITIAL POSTOP X-RAYS SHOWED GOOD PLACEMENT. MONTHS LATER, FOLLOW UP X-RAYS REVEALED THIS PLATE HAD BENT TO ABOUT A 90 DEGREE ANGLE; CLAVICLE HAD NOT HEALED. PT RETURNED TO HAVE PLATE REMOVED IN 2001. A NINE-HOLE 3.5 DC PLATE PLACE WAS USED FOR STABILIZATION DURING THIS SECOND SURGERY. PT WAS NOT INJURED. NO FURTHER PROBLEMS EXPECTED; HOWEVER, PATIENT DID HAVE TO GO THROUGH A SECOND SURGERY FOR FRACTURE FIXATION. THE 345 SYNTHES PLATE WAS SENT TO SYNTHES. SYNTHES ATTORNEY WAS NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39897 SYNTHES 8-HOLE, 345 RECONSTRUCTION PLATE -CLAVICAL- HRS SYNTHES 345 RECON PLATE *

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention