BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOMIZED MAND. RECON PLATE28 KIT, FULL

    MDR report key: 3930160 · Received July 11, 2014

    Report

    Report Number
    0008010177-2014-00180
    Event Type
    Malfunction
    Date Received
    July 11, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    PMA / PMN Number
    K132519
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BECAUSE THE COMPLAINED DEVICE AND ITS COMPONENTS WERE NOT RETURNED FOR INVESTIGATION, THE EVENT COULD NOT BE CONFIRMED. THE DHR REVIEW REVEALED THAT THE CUSTOMIZED RECON PLATE WAS MANUFACTURED ACCORDING TO THE SPECIFICATION. IN THE PRESENT CASE NEITHER THE CORRECT PROCEDURE TO ADJUST/BEND THE PLATE NOR THE CORRECT SCREWS HAVE BEEN USED. THE PLATE WAS BENT VIA INSERTING SCREWS INSTEAD OF USING THE INSTRUMENTATION FROM THE UNIVERSAL MANDIBULAR RECONSTRUCTION SYSTEM. FURTHERMORE THE PLATE WAS FIXATED WITH BONE SCREWS INSTEAD OF LOCKING SCREWS AS DESCRIBED IN THE IFU. CONSIDERING THESE CHOICES THE SURGICAL TECHNIQUE CAN BE CLASSIFIED AS AN OFF-LABEL USE. FURTHERMORE IN THE EVENT DESCRIPTION WAS COMPLAINED THAT THE IMPLANT DID NOT FIT PERFECTLY: APPROXIMATELY 4MM OFF TARGET. THE RELATED DHR WAS CHECKED AND FOUND TO BE WITHIN THE SPECIFIED VALUES: ALL DIMENSIONS WERE WITHIN THE TOLERANCES.

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED FOR EVALUATION AS IT WAS DISCARDED BY THE HOSPITAL. IF ADDITIONAL INFORMATION IS RECEIVED IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT. DEVICE DISCARDED.

    Description of Event or Problem · 1

    DURING A CUSTOMIZED MANDIBLE RECON PLATE (CMRP) PROCEDURE, THE LEFT SIDE OF THE PLATE DID NOT FIT PERFECTLY IN THE SUBCONDYLAR AREA. THE SUPERIOR PORTION OF THE LEFT SIDE OF THE CMRP APPEARED TO BE APPROXIMATELY 4MM OFF TARGET. THE SURGEON ELECTED TO PROCEED USING THE CMRP VERSUS A PLATE FROM THE UNIVERSAL MANDIBULAR RECONSTRUCTION MODULE. CONTRARY TO THE IFU, RATHER THAN MANUALLY USING A BENDER INCLUDED IN THE UNIVERSAL MANDIBULAR RECONSTRUCTION MODULE, THE SURGEON DECIDED TO ADJUST THE CMRP USING BONE SCREWS INSTEAD OF THE SCREWS VALIDATED FOR USE WITH THE CMRP (AS DESCRIBED IN THE IFU) ON THE SUPERIOR PORTION OF THE LEFT SIDE OF THE PLATE. THE SUBCONDYLAR AREA CRACKED WHEN TRYING TO GET THE PLATE FLUSH WITH THE BONE. A 2.8MM RECON BAR PLATE (FROM THE UNIVERSAL MANDIBULAR RECON MODULE) AND A TEMPORARY CONDYLAR PROSTHESIS WAS USED TO COMPLETE THE CASE.

    Description of Event or Problem · 1

    DURING A CUSTOMIZED MANDIBLE RECON PLATE (CMRP) PROCEDURE, THE LEFT SIDE OF THE PLATE DID NOT FIT PERFECTLY IN THE SUBCONDYLAR AREA. THE SUPERIOR PORTION OF THE LEFT SIDE OF THE CMRP APPEARED TO BE APPROXIMATELY 4MM OFF TARGET. THE SURGEON ELECTED TO PROCEED USING THE CMRP VERSUS A PLATE FROM THE UNIVERSAL MANDIBULAR RECONSTRUCTION MODULE. CONTRARY TO THE IFU, RATHER THAN MANUALLY USING A BENDER INCLUDED IN THE UNIVERSAL MANDIBULAR RECONSTRUCTION MODULE, THE SURGEON DECIDED TO ADJUST THE CMRP USING BONE SCREWS INSTEAD OF THE SCREWS VALIDATED FOR USE WITH THE CMRP (AS DESCRIBED IN THE IFU) ON THE SUPERIOR PORTION OF THE LEFT SIDE OF THE PLATE. THE SUBCONDYLAR AREA CRACKED WHEN TRYING TO GET THE PLATE FLUSH WITH THE BONE. A 2.8MM RECON BAR PLATE (FROM THE UNIVERSAL MANDIBULAR RECON MODULE) AND A TEMPORARY CONDYLAR PROSTHESIS WAS USED TO COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406334 CUSTOMIZED MAND. RECON PLATE28 KIT, FULL IMPLANT JEY STRYKER LEIBINGER FREIBURG 1406021003

    Patients

    Seq Age Sex Outcome Treatment
    1