BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CURVED BROAD LCP® PLATE 14 HOLES/265MM

    MDR report key: 4951751 · Received July 30, 2015

    Report

    Report Number
    9612488-2015-10387
    Event Type
    Injury
    Date Received
    July 30, 2015
    Report Date
    July 11, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HRS
    PMA / PMN Number
    PK082807
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: 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

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS COMPLETED: THE PLATE WAS DELIVERED IN 2 PARTS ¿ THEY IS BROKEN IN THE MIDDLE, SPLIT INTO 2 PIECES THE SURFACE WAS STRONGLY SCRATCHED. THE PLATE HAS A LOT OF USAGE MARKS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE AFFECTED LOT, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. ALL RELEVANT DIMENSIONS FOR THE FUNCTION OF THE PRODUCT WERE MEASURED AND FULFILL THE SPECIFICATIONS. THE MANUFACTURING OF THE PLATES WAS CORRECT, NO DEVIATIONS WERE DETECTED. THE RAW MATERIAL WAS RELEASED. BASED ON THIS THE COMPLAINT IS RATED AS CONFIRMED BUT NOT VALID FROM THE MANUFACTURING POINT OF VIEW. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. DEVICE WAS 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

    ADDITIONAL PRODUCT CODE: HWC (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. PART NUMBER: 226.642; LOT NUMBER: 2801818. MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: 10NOVEMBER2011. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THERE WAS A REMOVAL OF (13) THIRTEEN-HOLE BROAD CURVED PLATE AND CABLES AROUND A PROSTHESIS. IT WAS REPORTED THE PLATE BROKE AT A SCREW HOLE. THE FRACTURE WAS REVISED AND RE-PLATED WITH A (15) FIFTEEN-HOLE BROAD CURVED PLATE AND CABLES. NEW PLATE AND CABLES WERE DONE WITH NO PROBLEMS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    CORRECTION: THE REPORTED PLATE WAS A 14-HOLE CURVED BROAD LOCKING COMPRESSION PLATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496134 4.5MM CURVED BROAD LCP® PLATE 14 HOLES/265MM PLATE, FIXATION, BONE HRS SYNTHES BETTLACH 2801818

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention