BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM LCP® PROXIMAL FEMUR PLATE 4 HOLES/175MM-LEFT

    MDR report key: 3962202 · Received July 28, 2014

    Report

    Report Number
    3003506883-2014-10079
    Event Type
    Injury
    Date Received
    July 28, 2014
    Report Date
    July 1, 2014
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    PK030858
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 4.5MM PROXIMAL FEMUR PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED THIS LOT MET ALL SPECIFICATIONS WITH NO NON-CONFORMANCE NOTED. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT DETERMINED TO BE NOT CONFIRMED BASED ON THE DHR REVIEW ONLY. NO DEVICE WAS RETURNED FOR DIMENSIONAL INSPECTION. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE HOSPITAL CALLED TO INQUIRE ABOUT THE SYSTEM USED FOR THIS CASE AS THEY COULD NOT GET THE DETAILS FROM THEIR DATA, BY PROVIDING PATIENT DETAILS, DATA WAS RETRIEVED FROM SAP. PER THE HOSPITAL, THE PATIENT HAS A NONUNION AND AS A RESULT, THE IMPLANT BROKEN. THE PATIENT WILL HAVE A REVISION SURGERY IN INDIA. NO FURTHER DETAILS CAN BE PROVIDED. THIS COMPLAINT INVOLVES (3) DEVICES THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    439303 4.5MM LCP® PROXIMAL FEMUR PLATE 4 HOLES/175MM-LEFT PLATE,FIXATION,BONE HRS SYNTHES ELMIRA 6835135

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention