BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANDIBULAR RECON PLATTE, 17 HOLE, STRAIGHT, WITH TEMPLATE, STERILE

    MDR report key: 3191448 · Received June 26, 2013

    Report

    Report Number
    0008010177-2013-00130
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    May 27, 2013
    Report Date
    June 3, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K014263
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IN PROGRESS BUT NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE MACROSCOPIC AND MICROSCOPIC INVESTIGATIONS SHOWED THAT THE MANDIBULAR RECON PLATE, 17 HOLE, STRAIGHT, WITH TEMPLATE, STERILE BROKE IN LOW CYCLE FATIGUE MODE BY EXCEEDING THE MATERIAL STRENGTH AFTER A FEW CYCLES UNDER PARTIALLY VERY HIGH FORCES. THE FRACTURED SURFACE HAD APPEARANCE OF A FORCED RUPTURE AND A LOW CYCLE FATIGUE RUPTURE. MUCH EVIDENCE OF FORCED RUPTURE AND SECONDARY CRACKS ALSO EXISTED. IN ADDITION, SWINGING LINES OF A FATIGUE BREAKAGE WERE ALSO VISIBLE TO SOME EXTENT. THE ROOT CAUSE FOR THE REPORTED EVENT COULD HAVE BEEN ONE OR REPEATED POWERFUL DYNAMIC OVERLOAD AT THE FRACTURED AREA OF THE PLATE. NO INDICATIONS WERE FOUND FOR ANY SYSTEMATIC, DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 1

    ON 2013 (B)(6), THE REVISION SURGERY WAS PERFORMED WITH THE RECONSTRUCTION PLATE. AFTER THAT THE PLATE WAS BROKEN,AND THE REVISION SURGERY WAS PERFORMED AGAIN ON 2013 (B)(6). DURING THE SURGERY, WHEN SURGEON TRIED TO EXTRACT THE SCREWS, HEAD OF 2 SCREWS BROKE.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REVISION SURGERY WAS PERFORMED WITH THE RECONSTRUCTION PLATE. AFTER THAT THE PLATE WAS BROKEN,AND THE REVISION SURGERY WAS PERFORMED AGAIN ON (B)(6) 2013. DURING THE SURGERY, WHEN SURGEON TRIED TO EXTRACT THE SCREWS, HEAD OF 2 SCREWS BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291460 MANDIBULAR RECON PLATTE, 17 HOLE, STRAIGHT, WITH TEMPLATE, STERILE IMPLANT JEY STRYKER OSTEOSYNTHESIS-FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1