BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT SPECIFIC INSTR/PLAN KT ORTHOGNATHIC KIT, ONE SPLINT

    MDR report key: 4958090 · Received July 31, 2015

    Report

    Report Number
    3000270450-2015-10153
    Event Type
    Malfunction
    Date Received
    July 31, 2015
    Date of Event
    July 17, 2015
    Report Date
    July 17, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    JEY
    PMA / PMN Number
    PK103136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION NOT PROVIDED BY REPORTER. ADDITIONAL PRODUCT CODE: MQN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: SD900.009 - ME15ONONAD MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 07.JUL.2015, EXPIRY DATE: - NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. MFG. COULD NOT CONFIRM EXACTLY HOW THIS COMPLAINT OCCURRED, AS NO MATERIAL RECEIVED., THEREFORE THE INVESTIGATION SUMMARY COULD NOT BE PERFORMED BECAUSE PRODUCT WAS NOT RETURNED. NO FURTHER INFORMATION WAS AVAILABLE. 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

    REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN ORTHOGNATHIC PROCEDURE TOOK PLACE. IT WAS STATED THAT THE SPLINT WAS EITHER WARPED FROM HOSPITAL OR WAS MIDLINE OFF CENTRE. THE SURGEON PROCEEDED FREE HAND (WITHOUT GUIDANCE OF SPLINT) TO COMPLETE THE CASE. PATIENT HAD NO COMPLICATIONS. THE PROPLAN MAXILLA SPLINT WAS INCORRECT, THE DR UNABLE TO USE AS A GUIDE FOR THE SURGERY. DR. UN-SCRUBBED AND SURGERY DELAYED, UNABLE TO USE THE GUIDE, THERE WAS A 20 MINUTES DELAY IN SURGERY BECAUSE A SPARE DEVICE WAS NOT AVAILABLE AT THE TIME TO COMPLETE THE PROCEDURE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501240 PATIENT SPECIFIC INSTR/PLAN KT ORTHOGNATHIC KIT, ONE SPLINT BONE PLATE JEY SYNTHES SELZACH ME15ONONAD

    Patients

    Seq Age Sex Outcome Treatment
    1