BEUDAMED
    FDA Adverse Event Injury Summary report: N

    95 DEG DCS® PLATE 12 HOLES/210MM-STERILE

    MDR report key: 4266266 · Received November 20, 2014

    Report

    Report Number
    3000270450-2014-10156
    Event Type
    Injury
    Date Received
    November 20, 2014
    Report Date
    October 27, 2014
    Manufacturer
    SYNTHES SELZACH
    Product Code
    KTT
    PMA / PMN Number
    PK791619
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVERT DATE: EXACT DATE UNKNOWN, BUT IT WAS REPORTED AS TWO WEEKS AFTER THE IMPLANT DATE OF (B)(6) 2014. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON STERILE PART 281.925 / 2800815 WERE REVIEWED WITH THE FOLLOWING RESULT: NO ANOMALIES WERE DETECTED AT REVIEW, AND NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD 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.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; A BROKEN DYNAMIC CONDYLAR SCREW (DCS) PLATE WAS RECEIVED. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACE, WE CAN CONCLUDE THAT THE IMPLANT WAS SUBJECTED TO LOW DYNAMIC BENDING LOADS (TWO-SIDED). CONSTANT ALTERNATING LOAD CYCLES LED TO THE FATIGUE OF THE MATERIAL, THEN TO A FIRST CRACK AND FINALLY TO THE OVERLOAD RESPECTIVELY TO THE FATIGUE FRACTURE OF THE DCS PLATE. THE IMPLANT COULD NOT RESIST THE APPLIED FORCE WHICH FINALLY LED TO THE MATERIAL OVERLOAD I FATIGUE FAILURE. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PLATE BROKE AFTER TWO WEEKS. THE PLATE HAD BEEN IMPLANTED ON (B)(6) 2014. IT WAS EXPLANTED ON (B)(6) 2014. IT WAS REPORTED THAT THE SYNTHES PLATE HAD BEEN IMPLANTED DURING A REVISION PROCEDURE TO REPLACE A NON-SYNTHES PLATE THAT HAD BROKEN SIX MONTHS AFTER BEING IMPLANTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    754961 95 DEG DCS® PLATE 12 HOLES/210MM-STERILE APPLIANCE, FIXATION, NAIL KTT SYNTHES SELZACH 7677309

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention