BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI MATRIXMIDFACE SCREW SELF-TAPPING 4MM

    MDR report key: 2841269 · Received November 21, 2012

    Report

    Report Number
    2520274-2012-03273
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 25, 2012
    Manufacturer
    SYNTHES USA
    Product Code
    JEY
    PMA / PMN Number
    K083388
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS RETURNED TO SYNTHES ON (B)(4) 2013. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    AN EXPLANTED SYNPOR SMOOTH TITANIUM REINFORCED FAN PLATE, 1.5MM THICK WAS RETURNED TO SYNTHES ON JANUARY 17TH 2013 ALONG WITH ACCOMPANYING SCREWS. IT WAS DECONTAMINATED VIA AN AUTOCLAVE FOR FURTHER REVIEW AND ANALYSIS. THE DEVICE WAS REVIEWED BY PRODUCT DEVELOPMENT FOR THE FOLLOWING: (B)(4). INTEGRITY OF THE IMPLANT THROUGH VISUAL INSPECTION AND MANUAL MANIPULATION: THE INTEGRITY OF THE IMPLANT DID NOT APPEAR TO BE COMPROMISED. THERE WAS NO EVIDENCE OF DELAMINATION, FRACTURING OR SEPARATION OF THE POLYMER FROM THE REST OF THE IMPLANT. (B)(4). THE ADVERSE EVENT REPORT WAS RELATED TO SOFT TISSUE INFLAMMATION (REDNESS AND PUFFINESS IN THE ORBIT). SINCE THIS IS A BIOLOGICAL IN VIVO REACTION, IT IS NOT POSSIBLE TO REPRODUCE THE EVENT EX VIVO OR IN VITRO WITH THE RETURNED DEVICE. THUS THE SPECIFIC FAILURE MODE AND MECHANISM CANNOT BE DETERMINED. IT ALSO CANNOT BE DETERMINED IF THE ADVERSE EVENT WAS ATTRIBUTABLE TO THE DEVICE. CORRECTED DATA: DATE OF EVENT IS UNKNOWN. INITIAL REPORT INDICATED "(B)(6) 2012". INITIAL REPORT INDICATED "PLATE, SCREWS".

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH SYNPOR SMOOTH TI REINFORCED FAN PLATE AND SCREWS ON (B)(6) 2012. SURGEON DIAGNOSED PATIENT WITH REDNESS AND PUFFINESS IN THE ORBITAL SYNPOR IMPLANT REGION. PATIENT WAS RETURNED TO THE OR ON (B)(6) 2012 FOR REMOVAL OF HARDWARE. SURGEON REMOVED THE PLATE AND THREE 4MM SCREWS. THERE WAS NO REPORTED EVIDENCE OF INFECTION. THE SURGEON REPLACED THE IMPLANT WITH A SYNTHES TITANIUM ORBITAL FLOOR PLATE. THIS IS 4 OF 4 REPORTS FOR THE SAME EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI MATRIXMIDFACE SCREW SELF-TAPPING 4MM SCREW JEY SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention PLATE, SCREWS