BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LCP PLATE 12 HOLE/157MM

    MDR report key: 3062387 · Received April 16, 2013

    Report

    Report Number
    3003506883-2013-10111
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    September 16, 2011
    Report Date
    September 16, 2011
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL INFORMATION: THE PRODUCT DEVELOPMENT EVALUATION STATED THAT THE MATERIAL SPECIFIED ON THE DESIGN DRAWING ((B)(4)) IS CONSISTENT WITH OTHER SYNTHES IMPLANTS (EXCEPT FOR ANNEALED RECON PLATES). NOMINAL DIMENSIONS AND TOLERANCES ON THE DRAWING ARE ALSO CONSISTENT WITH THE HUMAN EQUIVALENT IMPLANTS.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. DEVICE IS A VETERINARY PRODUCT. DEVICE IS SIMILAR TO A DEVICE MARKETED FOR HUMAN USE. MANUFACTURING EVALUATION REPORTS THE PART WAS RECEIVED. A VISUAL INSPECTION OF THE PLATE NOTED THAT THE PLATE HAS A LARGE BEND IN THE MIDDLE OF THE PLATE. NO OTHER DAMAGE OR VISUAL ANOMALIES ARE NOTICED. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO COMPLAINT RELATED ANOMALIES AND ALL MEASUREMENTS FOR FEATURES RELEVANT TO THE COMPLAINT ARE CONFORMING. THE NOTED VISUAL DAMAGE NOTED IS POST-MANUFACTURING, THIS COMPLAINT IS DEEMED INVALID FROM A MANUFACTURING PERSPECTIVE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PLATE BENT 2 DAYS POSTOPERATIVELY. A REVISION SURGERY WAS REQUIRED. PATIENT INFO, (B)(6) AUSTRALIAN SHEPHERD WITH MIDSHAFT HIGHLY COMMINUTED FX.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162453 3.5MM LCP PLATE 12 HOLE/157MM HRS SYNTHES ELMIRA 6467127

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention