BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMARY MANDIBULAR RECONSTRUCTION PLATE, 11-HOLES, WITH TEMPLATE

    MDR report key: 14697610 · Received June 15, 2022

    Report

    Report Number
    0008010177-2022-00018
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    May 20, 2022
    Report Date
    August 30, 2022
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    UDI-DI
    04546540356376
    PMA / PMN Number
    K014263
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RECEIVED AT THE MANUFACTURER FOR TESTING. AN EVALUATION WILL BE CONDUCTED UPON RECEIPT OF THE DEVICE, AND A FOLLOW-UP REPORT WILL BE SUBMITTED AFTER THE QUALITY INVESTIGATION IS COMPLETE. IN ADDITION TO THE PRIMARY MANDIBULAR RECONSTRUCTION PLATE, 11-HOLES, WITH TEMPLATE (55-15911) THERE WERE ALSO A TOTAL QUANTITY OF 5 REPORTED SCREWS (50-20412 AND 50-20408 ) WHICH ARE CAPTURED IN COMPLAINTS # (B)(4).

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT ¿BREAKAGE - POSTOPERATIVE¿ COULD BE CONFIRMED, BECAUSE OF THE VISUAL INSPECTION. THE MACROSCOPIC APPEARANCE POINTS TO EXCEEDING THE MATERIAL STRENGTH. THAT IS CONFIRMED BY THE DETERIORATION OF THE ANODIZATION LAYER, THE CHANGES OF THE SURFACE¿S STRUCTURE AND THE SECONDARY CRACKS IN THE AREA OF THE BREAKAGE. STRONG PLASTIC DEFORMATIONS WITH MATERIAL BULGING AND A METAL COIL INDICATE HIGH FORCES ACTED ON THE PLATE DURING APPLICATION / REMOVAL. THE LOT NUMBERS ARE NOT AVAILABLE, AND NO POSTOPERATIVE CT-SCANS OR X-RAYS OF THE INITIAL SURGERY CAN BE PROVIDED. THE SENIOR GLOBAL MEDICAL DIRECTOR STATED THE PLATE WAS INSERTED APPROPRIATELY AND FOR THE CORRECT INDICATION. BASED ON THE PERFORMED INVESTIGATION, THERE IS NO INDICATION FOR AN INCORRECTLY WORKING PRODUCT OR ANY DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLATE WAS BROKEN AND A REVISION SURGERY WAS PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PLATE WAS BROKEN AND A REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2836183 PRIMARY MANDIBULAR RECONSTRUCTION PLATE, 11-HOLES, WITH TEMPLATE IMPLANT JEY STRYKER LEIBINGER FREIBURG 55-15911 NA 04546540356376

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention