BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NORIAN DRILLABLE INJECT 10CC-STERILE

    MDR report key: 6161020 · Received December 9, 2016

    Report

    Report Number
    2520274-2016-15648
    Event Type
    Injury
    Date Received
    December 9, 2016
    Report Date
    September 8, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    MQV
    PMA / PMN Number
    K102722
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TYPE OF REPORTABLE EVENT: MARKED AS MALFUNCTION BUT SHOULD BE SERIOUS INJURY. DEVICE 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

    DEVICE REMAINS IN THE PATIENT. 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

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. (B)(4) LOT NUMBER UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). 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

    THE PATIENT UNDERWENT A CALCANEUS OPEN REDUCTION INTERNAL FIXATION (ORIF). THE PROCEDURE WAS LONGER THAN THE AVERAGE PROCEDURE; THE PATIENT WAS OPEN FOUR TO FIVE (4-5) HOURS. THERE WAS DIFFICULT JOINT APPROXIMATION SO A DECISION WAS MADE TO PROCEED WITH THE NORIAN IMPLANT. THE SURGERY WAS TO PUT A PLATE IN OVER THE NORIAN. THE PATIENT HAD PERSISTENTLY DRAINING TRACT OUT OF THE BACK OF THE INCISION; THIS MAY HAVE BEEN SECONDARY TO THE NORIAN. THIS LED TO AN INFECTION AND EVENTUAL PLATE AND SCREW REMOVAL. THE NORIAN WAS LEFT IN AS THERE WAS NO DATA TO DETERMINE IF IT SHOULD BE REMOVED OR LEFT. THE PATIENT CONTINUES TO HAVE WOUND HEALING PROBLEMS AND CANNOT GRANULATE OVER THE MATRIX OF NORIAN. THE PATIENT IS NOW SEVEN (7) MONTHS OUT WITH AN ANKLE HELD IN PLACE WITH NORIAN AND UNABLE TO CLOSE THE SKIN OVER THE POSTERIOR HEEL. THE PLATE IS GONE. PLASTIC SURGERY IS RECOMMENDING A POSSIBLE FREE FLAP FOR TISSUE COVERAGE. SURGEON DOES NOT KNOW IF THE NORIAN NEEDS TO BE REMOVED FIRST OR IF IT IS WHAT IS PREVENTING THE SKIN FROM CLOSING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NORIAN WAS IMPLANTED AND AT THE IMPLANT SITE, AN INFECTION HAS BEEN NOTED. IT WAS NOTED THAT THERE WERE NO SIGNS OF INFECTION IN (B)(6) 2016. IT WAS REPORTED ON (B)(6) 2016 THAT INFECTION WAS PRESENT AND SURGEON DECIDED TO REMOVE HARDWARE. THIS COMPLAINT INVOLVES FOUR DEVICES. THIS REPORT IS 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810980 NORIAN DRILLABLE INJECT 10CC-STERILE N/A MQV SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention