BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT SPECIFIC SPLINT ORTHOGNATHIC, INTERMEDIATE

    MDR report key: 3081933 · Received April 29, 2013

    Report

    Report Number
    2520274-2013-11160
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    November 30, 2011
    Report Date
    December 2, 2011
    Manufacturer
    SYNTHES (USA)
    Product Code
    HWT
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING RETRACTED AS SYNTHES IS NOT THE MANUFACTURER OF THE DEVICE INVOLVED IN THIS INCIDENT. INITIAL MEDWATCH WAS FILED IN ERROR.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Description of Event or Problem · 1

    THE SURGEON MADE A CALL TO PRODUCT DEVELOPMENT TO ADVISE THAT WHILE USING THE INTERMEDIATE ORTHOGNATHIC SPLINT DURING A CASE THE SPLINT BROKE. THE SURGEON WAS ABLE TO FINISH THE CASE USING A BACK-UP SPLINT. THIS IS 1 OF 1 REPORTS FOR THIS EVENT, COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS 1OF 1 FOR FILE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185394 PATIENT SPECIFIC SPLINT ORTHOGNATHIC, INTERMEDIATE HWT SYNTHES (USA) MU11-UZE-CIQ

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR