BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP DISTAL HUMERAL PLATE R 8HO L194 SST

    MDR report key: 3230994 · Received July 17, 2013

    Report

    Report Number
    3003506883-2013-00308
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K031178
    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. DEVICE WAS RECEIVED (B)(4) 2013. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: RESULTS OF THE MANUFACTURING EVALUATION: INSPECTION PERFORMED DURING THIS EVALUATION AGAINST THE REQUIREMENTS AT THE TIME THE PART WAS RELEASED FOUND NOTHING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE COMPLAINT CONDITION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS PERFORMED AND STATED THE FOLLOWING: THE DEVICE HISTORY RECORDS (DHR) SHOWS THIS LOT OF 3.5MM DISTAL HUMERUS PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO SCRAP, NON-CONFORMANCES OR REWORK NOTED. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PATIENT HAD A REVISION SURGERY ON (B)(6) 2013 (INITIAL SURGERY PERFORMED ON 11/27/2012), AND IT WAS DISCOVERED THAT THE DISTAL HUMERAL PLATE WAS WORN OUT AND WAS PENETRATING THE BONE. THE PLATE WAS EXPLANTED; AND THE HEMOSTASIS WAS VERIFIED AND HUMERAL EXTERNAL TUTORS WERE INSTALLED. IT WAS ALSO REPORTED, A BONE FIXATION PLATE WITH ITS RESPECTIVE BONE SCREWS FROM A PRIOR PROCEDURE (DATE OF IMPLANT UNKNOWN) WAS UNSCREWED AND REMOVED FROM THE HUMERUS DURING THE SAME PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331093 LCP DISTAL HUMERAL PLATE R 8HO L194 SST HRS SYNTHES ELMIRA 7020175

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention