BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_FRO_PRODUCT

    MDR report key: 6831959 · Received August 30, 2017

    Report

    Report Number
    0008010177-2017-00221
    Event Type
    Injury
    Date Received
    August 30, 2017
    Date of Event
    August 11, 2017
    Report Date
    March 15, 2018
    Manufacturer
    STRYKER LEIBINGER FREIBURG
    Product Code
    JEY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OBSERVATION STATED IN THE REPORTED EVENT COULD NOT BE CONFIRMED, BECAUSE THE DEVICE WAS NOT RETURNED AND NO ADDITIONAL IMAGES WERE PROVIDED. AS PART OF THE DHR REVIEW THE AVAILABLE INFORMATION ON THE COMPLAINT IS BY DEFAULT FORWARDED TO THE MANUFACTURING SITE STRYKER ORTHOBIOLOGICS IN MALVERN (USA) TO REVIEW THE RELATED QUALITY AND MANUFACTURING DOCUMENTS. AS FOR THIS COMPLAINT THE LOT CODE # WAS NOT PROVIDED, A DHR REVIEW COULD NOT BE PERFORMED. TO GAIN A BETTER INSIGHT IN THE EVENT AND THE CONDITIONS THE PRODUCT HAD BEEN EXPOSED TO, THE CUSTOMER WAS CONTACTED. IT WAS STATED THAT THE APPLIED CUSTOMIZED IMPLANT BELONGS TO THE MEDPOR IMPLANT FAMILY AND IS NOT MADE OUT OF PEEK. FURTHERMORE IT WAS SPECIFIED THAT THE REVISION SURGERY WAS PERFORMED BECAUSE THE PATIENT ¿COULD JUST FEEL SOME OF THE IMPLANTED MATERIAL¿. THERE WAS NO INJURY OR DAMAGE AND THE SURGEON WANTED TO CONTOUR THE IMPLANT DOWN. FURTHER INFORMATION SUCH AS THE LOT NUMBER OF THE PRODUCT OR ADDITIONAL X-RAY IMAGES COULD NOT BE PROVIDED. THE PROVIDED INFORMATION WAS NOT SUFFICIENT ENOUGH TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. ACCORDING TO THE RELATED RISK MANAGEMENT FILE, POSSIBLE CAUSES FOR THE FAILURE MODE COULD HAVE BEEN: USE ERROR - SURGEON IMPROPERLY ORIENTS IMPLANT DURING INSERTION INTO THE PATIENT DEFECT ENVIRONMENTAL DISTURBANCE - UNANTICIPATED ANATOMICAL DEVIATION FROM ORIGINAL CT SCAN . BASED ON THE INVESTIGATION INCLUDING A STATISTICAL ANALYSIS THERE IS NO INDICATION FOR ANY DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE. THEREFORE NO CORRECTIVE AND/OR PREVENTIVE ACTIONS ARE DEEMED NECESSARY AT THAT TIME. THE COMPLAINT IS ADDED TO THE COMPLAINT TREND.

    Additional Manufacturer Narrative · 1

    DEVICE IS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE REPORTED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LEFT CUSTOM ORBITAL DEVICE IMPLANTED DURING AN INITIAL SURGERY 8 MONTHS AGO. NOW, A REVISION SURGERY IS SCHEDULED TO ADD MORE VOLUME AND ALSO PERFORM SOME SOFT TISSUE REPAIR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A LEFT CUSTOM ORBITAL DEVICE IMPLANTED DURING AN INITIAL SURGERY 8 MONTHS AGO. NOW, A REVISION SURGERY IS SCHEDULED TO ADD MORE VOLUME AND ALSO PERFORM SOME SOFT TISSUE REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612435 UNKNOWN_FRO_PRODUCT IMPLANT JEY STRYKER LEIBINGER FREIBURG

    Patients

    Seq Age Sex Outcome Treatment
    1