BEUDAMED
    FDA Adverse Event Injury Summary report: N

    135 DEG DHS PLATE-STANDARD BARREL 4 HOLES/78MM

    MDR report key: 2841303 · Received November 1, 2012

    Report

    Report Number
    3003506883-2012-00347
    Event Type
    Injury
    Date Received
    November 1, 2012
    Date of Event
    September 14, 2012
    Report Date
    October 4, 2012
    Manufacturer
    SYNTHES (USA)
    Product Code
    KTT
    PMA / PMN Number
    K791619
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DESIGN, COMPLAINT HISTORY AND RISK ANALYSIS INDICATES THAT THE DESIGN IS ADEQUATE FOR ITS INTENDED USE. BONY UNION IS DEPENDENT ON A MULTITUDE OF FACTORS, SUCH AS PROPER REDUCTION, BONE QUALITY, PATIENT COMPLIANCE, IMPLANT SELECTION, ETC. THE LACK OF ADDITIONAL INFORMATION PREVENTS A COMPLETE ANALYSIS OF THE CAUSE OF FAILURE. ADDITIONALLY, THE PATIENTS FALL MAY HAVE CAUSED A RE-FRACTURE.

    Additional Manufacturer Narrative · 1

    INFO FROM PRODUCT RETURNED. PART NUMBER (B)(4) MADE ON WORK ORDER (B)(4) AND LOT NUMBER 6724559 HAD NO NCRS. MATERIAL LOT 6678872 FROM WHICH THESE PARTS WERE MADE HAD NO NCRS AND CERTIFICATES WERE FOUND TO BE IN ORDER. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT HIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MFG OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE AS RECEIVED CONDITION OF THE PLATE WAS INTACT WITH SOME MINOR MARKING, SCRATCHING CONSISTENT WITH NORMAL FIELD USAGE. INSPECTION AND MEASUREMENT OF THE RETURNED PART SHOWS THAT IT MEETS ALL DIMENSIONAL AND VISUAL REQUIREMENTS FOR PERTINENT FEATURES THAT COULD BE RELATED TO THE CUSTOMER COMPLAINT.

    Description of Event or Problem · 1

    (B)(4) RECEIVED, A COPY WILL BE INCLUDED WITH THE REPORT. THIS IS 2 OF 7 REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 135 DEG DHS PLATE-STANDARD BARREL 4 HOLES/78MM DHS PLATE-STANDARD BARREL KTT SYNTHES (USA) 6724559

    Patients

    Seq Age Sex Outcome Treatment
    1 PLATE| SCREWS| LAG SCREW