BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR CUSTOMIZED CRANIAL-L

    MDR report key: 6515468 · Received April 24, 2017

    Report

    Report Number
    0008010177-2017-00088
    Event Type
    Injury
    Date Received
    April 24, 2017
    Date of Event
    March 28, 2017
    Report Date
    May 30, 2018
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    FWP
    PMA / PMN Number
    K143173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE OBSERVATION STATED IN THE REPORTED EVENT COULD NOT BE CONFIRMED, BECAUSE NOT ENOUGH INFORMATION WAS PROVIDED. TO GAIN A BETTER INSIGHT IN THE EVENT AND THE CONDITIONS THE PRODUCT HAD BEEN EXPOSED TO, THE CUSTOMER WAS CONTACTED. THE SURGEON DID NOT WANT TO PROVIDE ADDITIONAL INFORMATION AS HE ¿DID NOT FEEL THIS WAS AN IMPLANT ISSUE¿. THE DEVICE WAS MANUFACTURED BY STRYKER ORTHOBIOLOGICS IN (B)(4) (USA). ALL RELEVANT QUALITY DOCUMENTS (MANUFACTURING AND INSPECTION DOCUMENTS) HAVE BEEN REVIEWED. THE DEVICE HISTORY RECORD FOR CATALOG # 54440310, LOT CODE # K09757KM17 MAY INDICATE THAT (B)(4) DEVICE WAS MANUFACTURED AND RELEASED ON 2014-DEC-30 WITH NO REPORTED DISCREPANCIES. BASED ON THE INVESTIGATION, THE REVIEW OF ALL RELEVANT QUALITY DOCUMENTS AT THE MANUFACTURING SITE AND BASED ON THE ASSESSMENT OF THE SURGEON HIMSELF (¿DID NOT FEEL THIS WAS AN IMPLANT ISSUE¿), THERE IS NO INDICATION FOR A NOT CORRECTLY WORKING PRODUCT OR ANY SYSTEMATIC DESIGN, MATERIAL OR MANUFACTURING RELATED ISSUE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT DURING A CRANIAL SURGERY, IT WAS DISCOVERED THAT A NEW CRANIAL IMPLANT WAS ACTUALLY A REPLACEMENT FOR A MEDPOR CCI THAT WAS IMPLANTED IN EARLY 2015. THE PATIENT EXPERIENCED A MENINGIOMA WHICH PUSHED THE ORIGINAL MEDPOR CCI UP, CAUSING THE SCREWS TO BECOME DISENGAGED FROM THE BONE. THE TUMOR WAS REMOVED, AREA CLEANED, AND NEW IMPLANT PLACED IN THE PATIENT WITH NO ADDITIONAL ADVERSE CONSEQUENCES REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE COMPANY REPRESENTATIVE THAT DURING A CRANIAL SURGERY, IT WAS DISCOVERED THAT A NEW CRANIAL IMPLANT WAS ACTUALLY A REPLACEMENT FOR A MEDPOR CCI THAT WAS IMPLANTED IN EARLY 2015. THE PATIENT EXPERIENCED A MENINGIOMA WHICH PUSHED THE ORIGINAL MEDPOR CCI UP, CAUSING THE SCREWS TO BECOME DISENGAGED FROM THE BONE. THE TUMOR WAS REMOVED, AREA CLEANED, AND NEW IMPLANT PLACED IN THE PATIENT WITH NO ADDITIONAL ADVERSE CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298912 MEDPOR CUSTOMIZED CRANIAL-L IMPLANT FWP STRYKER ORTHOBIOLOGICS-MALVERN K09757KM17MAY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention