BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI QA+ #2/O OCORD V-5

    MDR report key: 9269039 · Received November 1, 2019

    Report

    Report Number
    1221934-2019-59396
    Event Type
    Injury
    Date Received
    November 1, 2019
    Date of Event
    August 19, 2019
    Report Date
    October 3, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    JDR
    UDI-DI
    10886705001835
    PMA / PMN Number
    K071257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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. INVESTIGATION SUMMARY: THE COMPLAINT DEVICE IS NOT BEING RETURNED, IT'S STILL IMPLANTED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. THIS COMPLAINT CANNOT BE CONFIRMED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3821597] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. SINCE THE COMPLAINT DEVICE IS IMPLANTED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF ADDITIONAL INFORMATION IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. AT THIS POINT IN TIME, NO CORRECTIVE ACTION IS REQUIRED, AND NO FURTHER ACTION IS WARRANTED. HOWEVER, DEPUY SYNTHES MITEK WILL CONTINUE TO TRACK ANY RELATED COMPLAINTS WITHIN THIS DEVICE FAMILY AS A MEANS OF MONITORING THE EXTENT WITH WHICH THIS COMPLAINT IS OBSERVED IN THE FIELD. DEVICE HISTORY LOT: A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [3821597] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). OCCUPATION: REPORTER IS PATIENT. (B)(4). 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

    IT WAS REPORTED BY THE PATIENT THAT AFTER A RADIAL HEAD REPLACEMENT AND DESPITE EXTENSIVE PHYSICAL THERAPY THE PATIENT IS EXPERIENCING STIFFNESS. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060473 MINI QA+ #2/O OCORD V-5 SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE JDR DEPUY MITEK LLC US 212035 3821597 10886705001835

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention