BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM TI LCP® PROXIMAL HUMERU PLATE-STANDARD 3H SHAFT/90MM

    MDR report key: 5438371 · Received February 16, 2016

    Report

    Report Number
    3006126083-2016-10009
    Event Type
    Injury
    Date Received
    February 16, 2016
    Report Date
    January 27, 2016
    Manufacturer
    SYNTHES RARON
    Product Code
    KTW
    PMA / PMN Number
    PK011815
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 06 JULY 2015, EXPIRY DATE: 01 JUNE 2025, NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE ORIGINALLY REPORTED 510K NUMBER WAS MISSING A DIGIT. CORRECTED TO REFLECT K011815. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT NEEDED A SURGERY FOR DEBRIDEMENT ON (B)(6) 2015 DUE TO DEEP WOUND INFECTION. ANTIBIOTICS, ANTICOAGULANTS (CLEXANE), ANALGESICS AND INTENSIVE CARE UNIT FOR PHYSIOTHERAPY. INFECTION AFTER THREE WEEKS TO SIX MONTHS POST-OP. ADDITIONAL INFORMATION RECEIVED VIA E-MAIL ON (B)(6) 2016: THE PATIENT HAD NO DEBRIDEMENT SURGERIES. PATIENT WAS STILL IN PAIN, HAD TO COME BACK TO HOSPITAL FOR CT. CT CONFIRMED THE AVASCULAR HUMERUS HEAD NECROSIS. PHILOS PLATE IS REMOVED AND THEY IMPLANTED A SHOULDER PROSTHESIS. PATIENT HAD NO COMPLICATIONS DURING THE POST-OP PERIOD AND LEFT THE HOSPITAL. THIS REPORT IS 1 OF 2 FOR COM-(B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS 1 OF 13 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94968 3.5MM TI LCP® PROXIMAL HUMERU PLATE-STANDARD 3H SHAFT/90MM APPLIANCE,FIXATION,NAIL/BLADE/ PLATE COMBO, SINGLE COMPONENT KTW SYNTHES RARON 9518910

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention