BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTEBRAL BODY SET/SMALL- STERILE

    MDR report key: 12460445 · Received September 13, 2021

    Report

    Report Number
    8030965-2021-07661
    Event Type
    Injury
    Date Received
    September 13, 2021
    Date of Event
    August 27, 2021
    Report Date
    August 29, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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. H3, H4, H6: PART # 09.804.600S. SYNTHES LOT # J002434. SUPPLIER LOT # 82213553. RELEASE TO WAREHOUSE DATE: 15FEB2021. EXPIRATION DATE: 01FEB2024. SUPPLIER: (B)(4). A NON-CONFORMANCE WAS GENERATED AND IS NOT RELEVANT TO THE ADVERSE IMPACT IN THE PRODUCT. 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

    COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2021 THE PATIENT UNDERWENT A KYPHOPLASTIE PROCEDURE AT L4 DUE TO OSTEOPOROTIC SINTERING FRACTURE. THE DESIRED REDUCTION COULD NOT BE ACHIEVED WITH THE VERTEBRAL BODY SET. THE PROCEDURE WAS COMPLETED USING CEMENT APPLICATION WITH JAMSHIDI NEEDLE. THERE WAS A SURGICAL DELAY OF FIVE TO TEN (5-10) MINUTES. THE PROCEDURE WAS COMPLETED WITHOUT THE DESIRED REPOSITION. THIS REPORT IS FOR ONE (1) VERTEBRAL BODY SET/SMALL- STERILE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357390 VERTEBRAL BODY SET/SMALL- STERILE ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH SYNTHES GMBH J002434

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention VBS W/BALLOON SM| VBS W/BALLOON SM