BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERTECEM V+ CEMENT KIT

    MDR report key: 8043558 · Received November 6, 2018

    Report

    Report Number
    8030965-2018-57969
    Event Type
    Injury
    Date Received
    November 6, 2018
    Date of Event
    September 25, 2018
    Report Date
    October 15, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NDN
    UDI-DI
    07611819376250
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. DEVICE HISTORY DEVICE HISTORY LOT PART: 07.702.016S, LOT: 7D53203, MANUFACTURING SITE: SELZACH , SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 21.AUG.2017 , EXPIRY DATE: 01.APR.2020 . THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 2010 PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NON-CONFORMANCE'S NOTED. THIS LOT MET ALL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. DEVICE HISTORY BATCH, NULL - DEVICE HISTORY REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE EVALUATION/INVESTIGATION/INVESTIGATION SUMMARY: COMPLAINT CAN BASICALLY BE CONFIRMED AS WE ARE ABLE TO SEE (ON CT SCAN) CEMENT LOCATED OUTSIDE THE VERTEBRAL BODY. PRODUCT WAS NOT RETURNED. 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.

    Additional Manufacturer Narrative · 1

    IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. REPORTER IS SYNTHES SALES REPRESENTATIVE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. (B)(4). DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE SURGEON WAS DISLOCATING A VERTEBRAL BODY SYSTEM (VBS) STENT FOR VERTEBROPLASTY IN THE MID THORACIC SPINE. AFTER CREATING THE APPROPRIATE LUMEN FOR THE BALLOON AND STENT, THE SURGEON WAS UNABLE TO INSERT THE STENT, A PESTLE WAS USED TO DILATE THE LUMEN, WITH THE PLUNGER BREAKING THROUGH THE ANTERIOR CORTICALIS AS WELL. WHEN THE SURGEON INTRODUCED THE STENT, A RESISTANCE WAS FELT AND COULD NOT PUSH THE STENT OUT OF THE SLEEVE INTO THE BONY LUMEN. A LITTLE MORE PRESSURE WAS APPLIED, AND THE STENT WENT IN JERKILY AND UNFORTUNATELY NOT ONLY IN THE BONY SPACE, BUT FURTHER FORWARD, AND REMAINED ONLY WITH THE BACK 1/3 IN THE BONE. DURING CEMENTATION, THE CEMENT, WHETHER CAUSED BY CEMENTATION OR NOT, THEN MOVED FREELY INTO THE SPACE BETWEEN THE AORTA AND PLEURA. A COMPUTED TOMOGRAPHY (CT) SCAN WILL BE PERFORMED AFTER THREE MONTHS TO SEE WHETHER THE CAGE IS MIGRATING. A DECISION ON REVISION DEPENDS ON THE RESULT OF THE INVESTIGATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO SURGICAL DELAY. THE PATIENT WAS STABLE AFTER THE PROCEDURE. ADDITIONAL CONCOMITANT MEDICAL PRODUCTS: INFLATION SYSTEM (PART: 03.804.413S, LOT: 8022618, QUANTITY:1); INFLATION SYSTEM (PART: 03.804.413S, LOT: 7052643, QUANTITY:1); VERTEBROPLASTY NEEDLE KIT 12-GAUGE CANNULATED (PART: 03.702.221S, LOT: AQL299, QUANTITY:1); VERTECEM V+ SYRINGE KIT (PART: 03.702.215S, LOT: 7072523, QUANTITY:1). THIS REPORT IS FOR ONE (1) VERTECEM V+ CEMENT KIT. THIS IS REPORT 3 OF 8 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883627 VERTECEM V+ CEMENT KIT POLYMETHYLMETHACRYLATE BONE CEMENT NDN OBERDORF SYNTHES PRODUKTIONS GMBH 7D53203 07611819376250

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention