BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP SUP-CLAVIC-PL 3.5 7HO LE L110 TAN

    MDR report key: 3247336 · Received July 25, 2013

    Report

    Report Number
    3003506883-2013-00322
    Event Type
    Malfunction
    Date Received
    July 25, 2013
    Date of Event
    July 1, 2013
    Report Date
    July 1, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K111540
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. REVIEW OF FINISHED PRODUCTS DEVICE HISTORY RECORD (PART NUMBER 04.112.083, LOT NUMBER 7130737, (B)(4)) DETERMINED THAT THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE, WITH NO IRREGULARITIES DOCUMENTED. REVIEW OF THE RAW MATERIAL BLANK DEVICE HISTORY RECORD (PART NUMBER 29012, LOT NUMBER 6864712, AND (B)(4)) FOUND NO IRREGULARITIES. REVIEW OF THE RESPECTIVE RAW MATERIAL, AND FINISHED PRODUCT DHR FILES FOUND NO IRREGULARITIES. BASED ON THIS INFORMATION ALONE, THIS COMPLAINT IS DEEMED INVALID. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(6) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: NON STERILE TITANIUM PLATE AND SCREWS WERE USED AS TEMPLATES. ALL CLAVICLE IMPLANTS ARE STERILE STAINLESS STEEL. SURGEON USED TITANIUM TRIAL IMPLANT TO FIX LEFT CLAVICLE FRACTURE WITH STAINLESS STEEL CORTEX AND CANCELLOUS SCREWS; THIS WAS A CLINICAL DECISION TO COVER THE NON-AVAILABILITY OF A USABLE TEMPLATE. SINCE THIS INCIDENT HAS OCCURRED, A FURTHER CLINICAL DECISION HAS BEEN MADE TO CONVERT ALL TITANIUM IMPLANTS TO STAINLESS STEEL, THUS PREVENTING ANY FURTHER INCOMPATIBILITY ISSUES. THE HOSPITAL PLANS TO MONITOR THE PATIENT AND PERFORM REMOVAL AT A LATER DATE WHEN THE FRACTURE HAS HEALED. REPORTEDLY THE HEALTH OF THE PATIENT HAS NOT BEEN COMPROMISED. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349424 LCP SUP-CLAVIC-PL 3.5 7HO LE L110 TAN HRS SYNTHES ELMIRA 7130737

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR