BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMATERIAL - CEMENT

    MDR report key: 10130625 · Received June 8, 2020

    Report

    Report Number
    1526439-2020-01146
    Event Type
    Injury
    Date Received
    June 8, 2020
    Report Date
    May 27, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NDN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE PATIENT INVOLVED. IMPLANTATION DATE IS UNKNOWN. 510K: THIS REPORT IS FOR AN UNKNOWN BIOMATERIAL - CEMENT/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. (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. (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN GERMANY AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ALHASHASH, M., SHOUSHA, M., BARAKAT, A.S., AND BOEHM, H. (2019), EFFECTS OF POLYMETHYLMETHACRYLATE CEMENT VISCOSITY AND BONE POROSITY ON CEMENT LEAKAGE AND NEW VERTEBRAL FRACTURES AFTER PERCUTANEOUS VERTEBROPLASTY: A PROSPECTIVE STUDY, GLOBAL SPINE JOURNAL, VOL. 9(7), PAGES 754-760 (GERMANY). THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE EFFECT OF BONE CEMENT VISCOSITY AS WELL AS OF BONE QUALITY ON CEMENT LEAKAGE DURING PERCUTANEOUS VERTEBROPLASTY AND TO ANALYZE THE FACTORS ASSOCIATED WITH THE OCCURRENCE OF NEW VERTEBRAL FRACTURES AFTER THE PROCEDURE. BETWEEN APRIL 2012 AND DECEMBER 2013, A TOTAL OF 60 PATIENTS WITH RECENT LUMBAR OR THORACIC VERTEBRAL COMPRESSION FRACTURES WITH UNSATISFACTORY PAIN RELIEF AFTER AT LEAST 4 WEEKS OF CONVENTIONAL THERAPY, AND A DIAGNOSIS OF OSTEOPOROSIS OR OSTEOPENIA WERE TREATED WITH A HIGH-VISCOSITY BONE CEMENT (CONFIDENCE SPINAL CEMENT SYSTEM, DEPUY SPINE INC, RAYNHAM, MA, USA) FOR 30 PATIENTS AND A LOW-VISCOSITY BONE CEMENT (OSTEOPAL V, HERAEUS MEDICAL GMBH, WEHRHEIM, GERMANY) FOR THE OTHER 30 PATIENTS. THERE WERE 18 FEMALES AND 12 MALES FOR THE HIGH VISCOSITY GROUP. ALL THE 60 PATIENTS WERE FOLLOWED UP FOR A MINIMUM OF 2 YEARS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 12 PATIENTS HAD INTRAOPERATIVE LEAKAGES. 22 PATIENTS HAD CEMENT LEAKAGES. 10 PATIENTS HAD NEW VERTEBRAL FRACTURES DURING THE PERIOD OF FOLLOW-UP. THIS REPORT IS FOR AN UNKNOWN SYNTHES HIGH-VISCOSITY BONE CEMENT (CONFIDENCE SPINAL CEMENT SYSTEM, DEPUY SPINE INC, RAYNHAM, MA, USA). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595039 UNKNOWN BIOMATERIAL - CEMENT POLYMETHYLMETHACRYLATE BONE CEMENT NDN MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention