BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICRO QA+ #3/0 OC V4

    MDR report key: 10760260 · Received October 30, 2020

    Report

    Report Number
    1221934-2020-03266
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    October 16, 2020
    Report Date
    October 16, 2020
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    HWC
    UDI-DI
    10886705002375
    PMA / PMN Number
    K080352
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H10 ADDITIONAL NARRATIVE: TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. INVESTIGATION SUMMARY ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT THE PATIENT HAS A FREE BODY AND DISLOCATED TEMPOROMANDIBULAR DISKS, THE DEVICES ARE IMPLANTED. THE COMPLAINT DEVICES WERE NOT RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. SINCE THE COMPLAINT DEVICES ARE IMPLANTED, WE CANNOT DETERMINE A ROOT CAUSE FOR THE REPORTED FAILURE. IF THE DEVICE IS RECEIVED IN THE FUTURE, WE WILL REOPEN THE COMPLAINT AND PERFORM THE INVESTIGATION AS APPROPRIATE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE [4L95823] NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. 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. UDI:(B)(4).

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. INVESTIGATION SUMMARY =ACCORDING TO THE INFORMATION PROVIDED, IT WAS REPORTED THAT ACCORDING TO THE SURGEON, PATIENT HAS A FREE BODY AND DISLOCATED TEMPOROMANDIBULAR DISK, ALSO IT WAS REPORTED BY THE SURGEON THAT THE PATIENT IS ON PAIN AND WITH MOUTH OPENING LIMITATION. THE COMPLAINT DEVICE IS NOT BEING RETURNED, THEREFORE UNAVAILABLE FOR A PHYSICAL EVALUATION. HOWEVER, AN X-RAY IMAGE WAS PROVIDED. UPON VISUAL INSPECTION OF THE X-RAY, IT COULD BE OBSERVED THAT THERE IS A FOREIGN OBJECT INSIDE THE PATIENTS TISSUE SURROUNDING BONE AREAS. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 4L95823 NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. AS PART OF DEPUY SYNTHES MITEK QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ACCORDING WITH THE X-RAY IMAGE REVIEW, THIS COMPLAINT CAN BE CONFIRMED. THE ROOT CAUSE FOR THE REPORTED PATIENTS CONDITION CAN BE ATTRIBUTED TO A USE THAT IS NOT LISTED IN THE IFU INDICATIONS. THE MICRO QA+ #3/0 OC V4 IS MADE OF NICKEL TITANIUM ALLOY (NITI) & 6AL-4V ELI. THE USE OF THIS ANCHOR IN A TEMPOROMANDIBULAR SURGERY IS NOT RECOMMENDED. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. B5: SUBSEQUENT FOLLOW-UP WITH THE CUSTOMER, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE SURGERY WAS PERFORMED ON (B)(6) 2020 BUT THE SURGEON REPORTED ON (B)(6) 2020 THAT THE PATIENT WAS ON PAIN AND WITH MOUTH OPENING LIMITATION. THIS REPORT IS BEING SUBMITTED IN PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY MITEK OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, MITEK, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. H11 CORRECTION NARRATIVE: B3: THE DATE OF EVENT HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION. B5: THE EVENT DESCRIPTION HAS BEEN UPDATED TO REFLECT THE CORRECT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE AFFILIATE IN PORTUGAL ON (B)(6) 2020 THAT POSTOPERATIVELY TO A TEMPOROMANDIBULAR PROCEDURE PERFORMED ON (B)(6) 2020 WHERE A MICRO QA+ #3/0 OC V4 WAS IMPLANTED, IT WAS OBSERVED THAT THE PATIENT HAD A FREE BODY AND DISLOCATED TEMPOROMANDIBULAR DISK. ACCORDING TO THE REPORTER, THE PATIENT WAS ON PAIN AND WITH MOUTH OPENING LIMITATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. UDI: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY AFFILIATE VIA COMPLAINT SUBMISSION TOOL 2 OF THE MICRO QA+ #3/0 OC V4. SURGEON DID A TEMPOROMANDIBULAR PROCEDURE ON A PATIENT. IN (B)(6) 2020, I SUBMITTED A COMPLAINT INCIDENCE REPORT WITH REGARDS TO THIS COMPLAINT: (B)(4) AND NOW THE SURGEON REPORTED THAT THE PATIENT IS NOT OK. ACCORDING TO THE SURGEON, PATIENT HAS A FREE BODY AND DISLOCATED TEMPOROMANDIBULAR DISK. THE DEVICES ARE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224916 MICRO QA+ #3/0 OC V4 SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE HWC DEPUY MITEK LLC US 212843 4L95823 10886705002375

    Patients

    Seq Age Sex Outcome Treatment
    1