BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VA-LCP CONDYLAR PLATE 4.5/5.0 R 16HO L33

    MDR report key: 2822670 · Received November 7, 2012

    Report

    Report Number
    8030965-2012-01206
    Event Type
    Injury
    Date Received
    November 7, 2012
    Report Date
    October 9, 2012
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    PMA / PMN Number
    K110354
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. THE INVESTIGATION IS ONGOING. NOTE: BLANK FIELDS ON THIS FORM INDICATE INFORMATION THAT IS UNKNOWN, UNAVAILABLE OR UNCHANGED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    (B)(4): MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. (B)(4): PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. ADD'L PRODUCT CODES: JDP, HWC. THE EXAMINATION OF THE RAW MATERIAL INSPECTION SHEETS AND THE MANUFACTURING PAPERS SHOWS THAT THE CHEMICAL COMPOSITION, MICROSTRUCTURE AND MECHANICAL PROPERTIES ARE IN COMPLIANCE WITH THE INTERNATIONAL STANDARDS ISO (B)(4) AND (B)(4). THE DIMENSIONS WERE FOUND TO BE IN ACCORDANCE WITH THE TECHNICAL DRAWING OF THE PRODUCER AND AO ASIF SPECIFICATIONS. WE ASSUME THAT AXIAL AND DOMINANT DYNAMIC BENDING LOADS LET TO THE FATIGUE OF THE PLATE. THE PLATE HAD TO ABSORB AND NEUTRALIZE FORCES THAT MAY HAVE BEEN GREATER THAN THE TOLERABLE LOAD. POSTOPERATIVE ACTIVITIES OF THE PATIENT MAY HAVE PLAYED A CERTAIN ROLE TOO. WE FOUND NO EVIDENCE OF MATERIAL OR MANUFACTURING DEFECTS.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT WAS IMPLANTED WITH VA-LCP CONDYLAR PLATE ON (B)(6) 2012. APPROXIMATELY SIX WEEKS LATER, (B)(6) 2012, THE PLATE WAS FOUND BROKEN. PLATE WAS REMOVED, DATE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VA-LCP CONDYLAR PLATE 4.5/5.0 R 16HO L33 VA-LCP CONDYLAR PLATE HRS SYNTHES GMBH 7677704

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention PLATE, SCREWS