BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROSTHESIS, INTERVERTEBRAL DISC

    MDR report key: 7034390 · Received November 15, 2017

    Report

    Report Number
    2530088-2017-10333
    Event Type
    Injury
    Date Received
    November 15, 2017
    Report Date
    October 23, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MJO
    PMA / PMN Number
    P050010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR TWO (2) UNKNOWN PRODISC L SUPERIOR ENDPLATES/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. 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

    PATIENT DATE OF BIRTH AND WEIGHT NOT AVAILABLE FOR REPORTING. DATE PATIENT ISSUES BEGAN IS NOT KNOWN. NUMBER 510K: THIS REPORT IS FOR AN UNKNOWN PRODISC L SUPERIOR ENDPLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE WAS NOT EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(4). DATE OF IMPLANT REPORTED AS (B)(6) 2004. 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

    PATIENT WAS IMPLANTED WITH PRODISC L AT DISC LEVELS L4-S1. THIS REPORT IS FOR TWO (2) UNKNOWN PRODISC L SUPERIOR ENDPLATES.

    Description of Event or Problem · 1

    CUSTOMER QUALITY UNIT RECEIVED A MAUDE REPORT FORWARDED FROM DEPARTMENT OF HUMAN SERVICES; THIS REPORT IS MW-5072704. ONLY ADDITIONAL AND/OR CORRECTED INFORMATION WILL BE CONTAINED IN THIS REPORT. IT WAS REPORTED THAT THE PATIENT WAS PART OF THE PRODISC L CLINICAL TRIAL. SOMETIME IN (B)(6) 2004 PATIENT WAS IMPLANTED WITH A TWO (2) LEVEL PRODISC L IMPLANT AT TWO UNKNOWN SPINE DISK SPACES. PATIENT REPORTED THAT THE INITIAL SURGERY WENT WELL. POST-OPERATIVE, PATIENT WENT BACK TO SCHOOL, BUT NOT WORK. PATIENT ALSO HAD BEEN RUNNING AFTER THE ORIGINAL SURGERY. PATIENT WAS IN A CAR ACCIDENT APPROXIMATELY ONE YEAR AFTER INITIAL SURGERY. THIS INCIDENT WAS REPORTED TO HIS SURGEON. PATIENT HAS BEEN BACK TO HIS DOCTOR AND TO MANY OTHER DOCTORS. ON AN UNKNOWN DATE POST-OPERATIVE, PATIENT WAS TOLD BY HIS SURGEON THAT THERE WAS SCAR TISSUE ON THE BACK OF HIS SPINE. ON AN UNKNOWN DATE, THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR ABDOMINAL SURGERY. DURING THIS PROCEDURE, THE SURGEON REMOVED THE SCAR TISSUE FROM THE FRONT OF THE SPINE WHICH WAS REPORTED AS CAUSING HIS SPINE ISSUES, BUT SURGEON DID NOT ADDRESS THE ISSUES TO THE BACK OF THE SPINE. CURRENTLY, PATIENT HAS HAD SURROUNDING ISSUES THAT HE HAS NOT HAD ASSISTANCE WITH AND HAVE NOT BEEN RESOLVED. CURRENTLY PATIENT HAS REPORTED THAT HE HAS RECURRING SYMPTOMS THAT INCLUDE SCAR TISSUE IN HIS BACK AND ABDOMEN, TROUBLE WALKING, AND IF HE STAYS STILL TOO LONG, HE LOCKS UP AND IS UNABLE TO MOVE. NO OTHER INFORMATION WAS REPORTED FROM THE PATIENT. THIS REPORT IS FOR ONE (1) UNKNOWN PRODISC L SUPERIOR ENDPLATE THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    811709 PROSTHESIS, INTERVERTEBRAL DISC MJO SYNTHES BRANDYWINE

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention