BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP VOL-DIST-RADIUSPL2.4 LE SHAFT 5HO HE

    MDR report key: 3353337 · Received September 17, 2013

    Report

    Report Number
    3003506883-2013-00355
    Event Type
    Injury
    Date Received
    September 17, 2013
    Date of Event
    July 24, 2013
    Report Date
    August 20, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K091644
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PART NUMBER 442.468 MADE ON WORK ORDER 2561231 AND LOT NUMBER 6602566 HAD NO NCRS. BLANK, BK100078, CREATED ON LOT NUMBER 6558770, WORK ORDER 2505428¿FROM WHICH THESE PARTS WERE MADE¿HAD NO NCRS. MATERIAL 6212619 FROM WHICH THESE BLANKS WERE MADE HAD ONE NCR, US1024582, FOR SCRATCHES ON SURFACE OF THE MATERIAL. MATERIAL WAS DISPOSITIONED UAI AS THE MANUFACTURING PROCESS REMOVES SOME SURFACE ANOMALIES. COMPLETED PRODUCT IS VISUALLY INSPECTED AT 100% FOR COSMETICS AT FINAL INSPECTION. ANY VISUAL NONCONFORMANCE CREATED AS A RESULT OF THIS NONCONFORMANCE WOULD BE CAPTURED AT FINAL INSPECTION. THIS NONCONFORMANCE COULD NOT CONTRIBUTE TO THE COMPLAINT CONDITION. CERTIFICATES WERE FOUND TO BE IN ORDER. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE AND THERE WERE NO ISSUES DOCUMENTED DURING THE MANUFACTURING OF THESE PARTS THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS NOT RETURNED AND NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: PLATE IS BROKEN. THE PATIENT HAD A DISTAL RADIUS FRACTURE. ON (B)(6) 2013, THE SURGEON PERFORMED AN OPERATION WITH A PLATE OF LCP VOL- DIST-RADIUS PL2.4 LE SHAFT 5HO H (442.468S). AFTER THE OPERATION, THE BONE WAS PROTECTED WITH A SPLINT. AFTER ABOUT ONE AND A HALF MONTHS FROM THE OPERATION, THE BONE STILL SEEMED NOT TO HEAL BY X-RAY OBSERVATION. ON (B)(6) THE PLATE WAS BROKEN. THE DATE OF EXPLANT WAS NOT REPORTED AT THIS TIME. THIS IS 1 OF 1 REPORT FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467566 LCP VOL-DIST-RADIUSPL2.4 LE SHAFT 5HO HE HRS SYNTHES ELMIRA 6602566

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention