BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT SPECIFIC INSTR/PLAN KT ORTHOGNATHIC KIT, TWO SPLINTS

    MDR report key: 6224910 · Received January 5, 2017

    Report

    Report Number
    3000270450-2017-10002
    Event Type
    Malfunction
    Date Received
    January 5, 2017
    Date of Event
    December 10, 2016
    Report Date
    December 10, 2016
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JEY
    PMA / PMN Number
    K103136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT DATE OF BIRTH AND WEIGHT ARE NOT AVAILABLE FOR REPORTING. (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART # SD900.008, LOT # ME16-HEJ-GAF. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: NOV 30, 2016. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    ADDITIONAL NARRATIVE: A MANUFACTURING INVESTIGATION WAS PERFORMED ON THE SUBJECT DEVICE. THE RECEIVED KIT (PARTS) WAS FORWARDED TO THE RESPONSIBLE MANUFACTURER FOR INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE AFFECTED LOT, NO ABNORMALITIES OR DEVIATIONS WERE DETECTED, WHICH COULD LEAD TO THE COMPLAINT FAILURE. THE ARTICLE WAS MANUFACTURED IN NOVEMBER 2016. NO NON CONFORMANCE REPORTS (NCRS) WERE MARKED IN THE DHR DURING PRODUCTION. FOR THIS COMPLAINT, THE DEVICE HISTORY RECORD WAS INVESTIGATED. NO INACCURACIES WERE FOUND ON THE IMAGE QUALITY, SEGMENTATION, PLANNING AND GUIDE DESIGN STEPS. THE FINAL OCCLUSION WAS SET DURING THE PLANNING SESSION WITH THE SURGEON, WHICH ACCOUNTED FOR AN OPEN BITE OF 1.5MM WHEN MEASURING AT THE LEVEL OF THE MAXILLARY AND MANDIBULARY MIDLINES OF THE CENTRAL INCISORS. THE FINAL POSITION OF THE BIMAX COMPLEX IS SHOWN AND DISCUSSED IN THE PLANNING SESSION WITH THE SURGEON, AND AS WELL IS SHOWN IN THE CASE REPORT PROVIDED TO THE SURGEON FOR ITS APPROVAL. THEREFORE, IT CAN BE CONCLUDED THAT THE SPLINT WAS DESIGNED BASED ON THE APPROVED PREFERENCES OF THE SURGEON AND IN CONSEQUENCE THIS IS THE ROOT CAUSE OF THIS COMPLAINT. THE DEVICE MEETS THE SPECIFICATIONS. ROOT CAUSE PROCESS CATEGORY: PLANNING; USER ERROR ¿ SURGEON. NO PRODUCT FAULT COULD BE DETECTED. NO CORRECTIVE ACTION REQUIRED. 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

    TWO (2) PARTS FROM THE KIT SD900.008 WERE RECEIVED: SD900.105 AND SD900.106. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 EUROPE REPORTS AND EVENT IS (B)(6) AS FOLLOW: IT WAS REPORTED THAT ON (B)(6) 2016 PATIENT UNDERWENT A BIMAXILLARY OSTEOTOMY SURGERY WITH GENIOPLASTY PROCEDURE USING PROPLAN SPLINTS, WITH MANDIBLE MOVEMENT FIRST. THE INTERMEDIATE SPLINT WAS FINE. THE FINAL SPLINT, MAXILLA MOVEMENT, RESULTED IN AN ANTERIOR OPEN BITE OF ABOUT 1.5MM. POSTERIOR REGION WAS OK. THE ANTERIOR OPEN BITE WAS IDENTIFIED AFTER THE MAXILLA WAS PLATED AND THE SPLINT REMOVED. THIS MEANT THAT THE MAXILLA PLATES HAD TO BE REMOVED, AND THE JAW WAS RE-WIRED WITHOUT A SPLINT FOR THE FINAL POSITION. NEW PLATES WERE PUT IN. THIS CAUSED AN APPROXIMATE 30MIN DELAY TO THE SURGERY. SURGEON DESCRIBED THE ISSUE AS THE FINAL SPLINT APPEARING TOO THICK IN THE ANTERIOR REGION, DESPITE ORDERING THE THINNEST SPLINT AVAILABLE. THERE WAS NO ADVERSE EVENT TO THE PATIENT. THE SURGEON IS HAPPY WITH OUTCOME AFTER THE FINAL SPLINT WAS NOT USED THE SECOND TIME AROUND. THIS REPORT IS FOR ONE (1) PATIENT SPECIFIC INSTRUMENT/PLAN KT ORTHOGNATHIC KIT, TWO SPLINTS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10707 PATIENT SPECIFIC INSTR/PLAN KT ORTHOGNATHIC KIT, TWO SPLINTS BONE PLATE JEY SYNTHES SELZACH ME16HEJGAF

    Patients

    Seq Age Sex Outcome Treatment
    1