BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TI OBA PLATE ANCHOR BRACKET DESIGN 4 HOLES

    MDR report key: 5551932 · Received April 6, 2016

    Report

    Report Number
    2520274-2016-11993
    Event Type
    Malfunction
    Date Received
    April 6, 2016
    Date of Event
    March 23, 2016
    Report Date
    March 23, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    OAT
    PMA / PMN Number
    PK093299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THIS COMPLAINT IS CONFIRMED AS THE RETURNED PLATE WAS RECEIVED IN TWO PIECES (PLATE SECTION WITH 4 HOLES IS SEPARATE FROM THE ANCHOR BRACKET SECTION). IN ADDITION TO BEING SHEARED IN HALF, THE RETURNED PLATE IS BENT IN SEVERAL AREAS. A THICKNESS MEASUREMENT OF 0.71MM WAS ABLE TO BE TAKEN JUST ADJACENT TO THE AREA OF PLATE BREAKAGE USING CALIPERS. PER THE RELEVANT DRAWING THE THICKNESS IS TO BE 0.70MM - 0.80MM. THEREFORE, THE PLATE THICKNESS MEASURES WITHIN SPECIFICATIONS. WHETHER THIS COMPLAINT CAN BE REPLICATED IS NOT APPLICABLE AS THE PLATE IS ALREADY BROKEN IN TWO PIECES. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE. HOWEVER, THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY OVER-BENDING. IT IS NOT LIKELY THAT THE DESIGN OF THE DEVICE CONTRIBUTED TO THIS COMPLAINT. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED, IT DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION. THE RELEVANT DRAWING WAS REVIEWED DURING THIS EVALUATION. THE PLATE WAS MADE FROM COMMERCIALLY PURE GRADE 4 TITANIUM AND ANODIZED PER SPECIFICATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. 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

    A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. SUPPLIER: MAGNUM TOOL COMPANY. RELEASE TO WAREHOUSE DATE (MANUFACTURING DATE): APR 2, 2012. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    (B)(4). DEVICE NOT IMPLANTED OR EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE 04.500.013 BROKE WHILE BEING BENT BY SURGEON DURING SURGERY. THE PLATE WAS NOT OVER BENT. SURGEON USED A NEW PLATE. FIVE MINUTES DELAY. NO ADVERSE EVENT. NO PATIENT HARM. THIS COMPLAINT INVOLVES ONE PART. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207386 TI OBA PLATE ANCHOR BRACKET DESIGN 4 HOLES IMPLANT, ENDOSSEOUS, ORTHODONTIC OAT SYNTHES MONUMENT 6879038

    Patients

    Seq Age Sex Outcome Treatment
    1