BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM

    MDR report key: 6795833 · Received August 15, 2017

    Report

    Report Number
    3003506883-2017-10162
    Event Type
    Injury
    Date Received
    August 15, 2017
    Report Date
    July 21, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    UDI-DI
    10886982033130
    PMA / PMN Number
    K111540
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE & WEIGHT NOT AVAILABLE FOR REPORTING. ORIGINAL IMPLANT DATE IS UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. UNKNOWN THERAPY DATE. THE 510K: ADDITIONAL 510K - K111540. (B)(4). NO DHR REVIEW CAN BE COMPLETED SINCE THE LOT NUMBER PROVIDED IS INACCURATE OR INCOMPLETE. THE LOT NUMBER PROVIDED IS "8266962". DHR REQUESTED. PRODUCT WAS NOT RETURNED AND LOT NUMBER PROVIDED IS INCORRECT. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). 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

    IT WAS REPORTED ON (B)(6) 2017 A REVISION SURGERY WAS PERFORMED FOR A BROKEN 3.5 MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100 MM DUE TO NON-UNION. THE PATIENT WAS EXPERIENCING PAIN IN RIGHT CLAVICLE AND IT WAS DISCOVERED THAT THE IMPLANTED CLAVICLE PLATE WAS BROKEN. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY, THERE WERE NO SURGICAL DELAYS, NO FRAGMENTS WERE GENERATED FROM BROKEN DEVICE, NO ADDITIONAL X-RAYS TAKEN AND NO OTHER MEDICAL INTERVENTION REQUIRED. A NEW DEPUY SYNTHES CLAVICLE PLATE WAS IMPLANTED INTO THE PATIENT AND THE PATIENT STATUS WAS REPORTED AS STABLE. CONCOMITANT PART: SCREWS (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY SEVEN). THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574363 3.5MM LCP SUPERIOR CLAVICLE PLATE/7 HOLE/RIGHT/100MM PLATE,FIXATION,BONE HRS SYNTHES ELMIRA 02.112.082 8266962 10886982033130

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention