BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDPOR CUSTOMIZED CRANIAL-XL

    MDR report key: 6358799 · Received February 24, 2017

    Report

    Report Number
    0008010177-2017-00032
    Event Type
    Injury
    Date Received
    February 24, 2017
    Date of Event
    November 30, 2016
    Report Date
    June 29, 2018
    Manufacturer
    STRYKER ORTHOBIOLOGICS-MALVERN
    Product Code
    FWP
    PMA / PMN Number
    K121315
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    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 AT THE USER FACILITY.

    Additional Manufacturer Narrative · 1

    DUE TO THE NATURE OF THE COMPLAINT, THE OBSERVATION STATED IN THE REPORTED EVENT COULD NOT BE CONFIRMED. TO GAIN A BETTER INSIGHT IN THE EVENT AND THE CONDITIONS THE PRODUCT HAD BEEN EXPOSED TO, THE SALES REPRESENTATIVE WAS CONTACTED. IT WAS SPECIFIED THAT THIS REPORTED EVENT WAS THE SECOND OUT OF THREE COMPLAINED EVENTS, DOCUMENTED BY PI # (B)(4) (EVENT), PI # (B)(4) (EVENT) AND PI # (B)(4) ( EVENT). ALL THREE REPORTED EVENTS ARE LINKED TO THE SAME PATIENT. WITH RESPECT TO THE EVENT IT WAS INDICATED THAT THE SURGERY WAS PERFORMED ON (B)(6) 2016 AND AN INFECTION DID NOT OCCUR. DUE TO A HEMATOMA THE IMPLANT WAS THEN EXPLANTED ON (B)(6) 2016 AND REPLACED BY A NEW CUSTOM CRANIAL IMPLANT. EVEN THIS WAS NOT EXPLICITLY CONFIRMED BY THE SALES REP IT IS HIGHLY LIKELY THAT THE ¿NEW¿ CUSTOM CRANIAL IMPLANT WAS THE SECOND STERILE IMPLANT IN THE PACKAGE THAT WAS DELIVERED TO THE CUSTOMER AS PART OF THE CUSTOMIZED IMPLANT CASE WITH ID 1606161009. THIS ASSUMPTION IS PROBABLE BECAUSE OF THE SHORT DURATION BETWEEN THE DATES OF IMPLANTATION AND EXPLANTATION (12 DAYS), THE NOT YET EXCEEDED EXPIRATION DATE OF THE TWO IMPLANTS (2016-NOV-30) AND THE FACT THAT THE PRODUCT LOT NUMBER IN THE THIRD REPORTED EVENT (PI #(B)(4)) IS STILL 1606161009. 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 # 54440410, LOT CODE # 1606161009 INDICATES THAT (B)(4) DEVICE WAS MANUFACTURED AND RELEASED ON 2016-JUL-07 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 RISK MANAGEMENT BOARD, THERE IS NO INDICATION FOR A NOT CORRECTLY WORKING PRODUCT OR ANY SYSTEMATIC 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT A CUSTOM CRANIAL IMPLANT WAS REMOVED IN (B)(6) OF 2016 DUE TO VASCULARIZATION ISSUES AND A HEMATOMA EXPERIENCED BY THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REPRESENTATIVE THAT A CUSTOM CRANIAL IMPLANT WAS REMOVED IN (B)(6) OF 2016 DUE TO VASCULARIZATION ISSUES AND A HEMATOMA EXPERIENCED BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    141107 MEDPOR CUSTOMIZED CRANIAL-XL IMPLANT FWP STRYKER ORTHOBIOLOGICS-MALVERN 1606161009

    Patients

    Seq Age Sex Outcome Treatment
    1