BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PSI SD800.434 PEEK IMPLANT

    MDR report key: 8152569 · Received December 11, 2018

    Report

    Report Number
    8030965-2018-58919
    Event Type
    Injury
    Date Received
    December 11, 2018
    Date of Event
    January 1, 2018
    Report Date
    November 20, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    GXN
    UDI-DI
    07611819341340
    PMA / PMN Number
    K053199
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H3, H4, H6: PART: SD800.434, LOT: L922146, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: MAY 30, 2018, DESIGN REVIEW. AN INVESTIGATION WAS CONDUCTED INTO THE DEVICE DESIGN TO DETERMINE IF THE DESIGN CONTRIBUTED OR CAUSED THE EVENT. THE CT SCAN INFORMATION OF THIS CASE WAS PROVIDED TO DEPUY SYNTHES R&D ON MAY 16, 2018. THE CT SCAN DID NOT MEET THE REQUIREMENTS SPECIFIED IN THE CT/CBCT SCAN PROTOCOL TO CONTINUE WITH THE IMPLANT DESIGN. THE CRANIUM IN THIS CASE SHOWED A DEFECT ON THE RIGHT SIDE OF THE PATIENT. THE DESIGN FOR THE IMPLANT WAS CREATED ACCORDING TO THE RELEVANT WORK INSTRUCTION FOR PSI DESIGN. THE IMPLANT WAS DESIGNED WITH A STANDARD THICKNESS OF 4 MM AND AN OFFSET FROM THE PSI TO THE DEFECT OF 0.2 MM. THE APPROVAL DOCUMENT WAS CREATED WITH A DISCLAIMER FOR UNCOMPLIANT CT SCANS CALLING OUT THE FOLLOWING INFORMATION: ¿PSI BASED UPON CT-SCAN NOT FULLY COMPLIANT WITH OUR CT REQUIREMENTS.¿ UPON SURGEON APPROVAL, A FUNCTIONAL CHECK DEVICE WAS 3D PRINTED AND CHECKED BY AN INDEPENDENT DESIGNER WHO REVIEWED THE PHYSICAL VERIFICATION MODEL AGAINST THE CASE FILE AND FOUND THE DEVICE TO BE ACCEPTABLE AND APPROVED THE DESIGN. THE REVIEW OF THE CASE FILE ¿PATIENT SPECIFIC IMPLANT DESIGN REVIEW CHECKLIST¿ FOR THIS IMPLANT SHOWED THAT THE IMPLANT WAS REVIEWED AND APPROVED BY AN INDEPENDENT REVIEWER ACCORDING TO THE RELEVANT WORK INSTRUCTION FOR PSI DESIGN. PAGE 2/3 THE DRAINAGE HOLE SELECTION BOX ON THE PSI-ROUTER DOCUMENT WAS FALSELY CHECKED ¿NO¿. THIS SELECTION WAS NOT RESET TO ¿YES¿ UPON THE CHECK OF THE RELEASE OF THE MANUFACTURING FILES. PER THE DESCRIPTION, THE ABOVE PSI CASE FILE WAS REVIEWED. THE INVESTIGATION INCLUDED A REVIEW OF THE DOCUMENTATION, FORMS, DIGITAL MODEL (CAD) FILES, ALONG WITH THE SURGEON REPORT. THE DESIGN WAS COMPLETED AND VERIFIED AS PER THE DESIGN INSTRUCTIONS. HOWEVER, THE INCORRECT SELECTED ¿HOLES¿ CHECK BOX ON THE MANUFACTURING ROUTER LED TO THE COMPLAINT DESCRIPTION ¿THAT THERE WAS NO HOLE ON THE IMPLANT (...)¿ BASED ON OUR PROCESS, THESE DEVICES HAVE DRAINAGE HOLES, UNLESS SPECIFICALLY REQUESTED BY THE SURGEON NOT TO HAVE THESE. PD IS RESPONSIBLE TO SELECT THE RIGHT BOX ON THE ROUTER DOCUMENT. THEREFORE, THIS NON-MANUFACTURING EVALUATION IS CLOSED AS A VALID COMPLAINT REGARDING A DESIGN RELATED ISSUE. RELEVANT ACTIONS HAVE BEEN TAKEN TO ADDRESS THE ISSUE. CONCLUSION THE COMPLAINT WAS CONFIRMED DURING INVESTIGATION. DURING THE INVESTIGATION, NO MANUFACTURING ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. RELEVANT ACTIONS HAVE BEEN TAKEN TO ADDRESS THE ISSUE. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THEREFORE, IT HAS BEEN DETERMINED THAT NO ADDITIONAL CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE PATIENT COMPLAINED OF DISCOMFORT AND RETURNED TO THE SURGICAL FACILITY ON (B)(6) 2018. A SUBDURAL EFFUSION WAS THEN NOTED. PATIENT WAS INITIALLY IMPLANTED WITH A POLYETHERETHERKETONE (PEEK) PATIENT SPECIFIC IMPLANT (PSI) ON (B)(6) 2018. THERE WAS NOT A HOLE ON THE IMPLANT WHERE THE SURGEON HAD TO MANUALLY DRILL A HOLE TO COMPLETE THE PROCEDURE. NO ISSUE WAS OBSERVED DURING THE PROCEDURE. THE PATIENT IS NOW AT THE FACILITY FOR MONITORING AND THE DEVICE IS STILL IMPLANTED. THIS REPORT IS FOR ONE (1) PSI SD800.434 PEEK IMPLANT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    992981 PSI SD800.434 PEEK IMPLANT PLATE,CRANIOPLASTY,PREFORMED, NONALTERABLE GXN OBERDORF SYNTHES PRODUKTIONS GMBH L922146 07611819341340

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention