BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN BIOMATERIAL - CEMENT

    MDR report key: 10113266 · Received June 2, 2020

    Report

    Report Number
    1526439-2020-01107
    Event Type
    Injury
    Date Received
    June 2, 2020
    Report Date
    May 21, 2020
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    NDN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). 510K: THIS REPORT IS FOR AN UNKNOWN BIOMATERIAL - CEMENT/UNKNOWN LOT NUMBER. WITHOUT THE SPECIFIC PART NUMBER, THE UDI NUMBER AND 510K NUMBER IS UNKNOWN. 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 AS NO PRODUCT WAS RECEIVED. INVESTIGATION SUMMARY: 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, 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. (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: RUSTAGI, T. ET AL (2020), TRANSPEDICULAR VERTEBRECTOMY WITH CIRCUMFERENTIAL SPINAL CORD DECOMPRESSION QND RECONSTRUCTION FOR THORACIC SPINE METASTASIS: A CONSECUTIVE CASE SERIES, SPINE AN INTERNATIONAL JOURNAL FOR THE STUDY OF THE SPINE, VOL. XX (XX), PAGES 1-25 (USA). THE AIM OF THIS RETROSPECTIVE STUDY IS TO STUDY THE FEASIBILITY, OUTCOMES AND COMPLICATIONS OF TRANSPEDICULAR VERTEBRECTOMY (TPV) AND RECONSTRUCTION FOR METASTATIC LESIONS TO THE THORACIC SPINE. BETWEEN JANUARY 2008 TO DECEMBER 2016, A TOTAL OF 96 PATIENTS (48 MALE AND 48 FEMALE) WITH A MEAN AGE OF 60 YEARS (IQR: 51-65 YEARS) UNDERWENT TRANSPEDICULAR VERTEBRECTOMY (TPV). RECONSTRUCTION OF THE ANTERIOR COLUMN FOLLOWING VERTEBRECTOMY WAS PERFORMED USING PMMA CEMENT IN 78 PATIENTS AND TITANIUM CAGE IN 18 PATIENTS. CEMENT RECONSTRUCTION WAS PERFORMED USING CONFIDENCE® (DEPUY, RAYNHAM, MA). THE FOLLOW-UP PERIOD WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: TOTAL 59 DEATHS WERE OBSERVED. THE MEDIAN SURVIVAL TIME WAS ESTIMATED TO BE 6 MONTHS (95% CI: 5, 10). 3 PATIENTS DIED WITHIN 30 DAYS. 3 PATIENTS (CAGE) AND 7 PATIENTS (CEMENT) HAD OPERATIVE COMPLICATIONS. 7 PATIENTS (CAGE) AND 20 PATIENTS (CEMENT) HAD POSTOPERATIVE COMPLICATIONS. 6 PATIENTS HAD A DUROTOMY/CSF LEAK. 3 PATIENTS HAD A SUPERFICIAL INFECTION. 1 PATIENT HAD A PLEURAL TEAR. 4 PATIENTS HAD PNEUMONIA. 3 PATIENTS HAD A URINARY INFECTION. 3 PATIENTS HAD DEEP VENOUS THROMBOSES (DVT). 2 PATIENTS DEVELOPED PROGRESSIVE WEAKNESS IN THE IMMEDIATE POSTOPERATIVE PERIOD DUE TO EPIDURAL HEMATOMA, REQUIRING EMERGENT HEMATOMA EVACUATION; NEUROLOGICAL FUNCTION RETURNED TO BASELINE IN BOTH CASES. 1 PATIENT WAS REINTUBATED. 1 PATIENT HAD STROKE. IN MOST CASES, FRANKEL GRADE DID NOT CHANGE FOLLOWING SURGERY (FIGURE 3). OF THE 18 CASES, WHERE CHANGE WAS SEEN, 16 (88.8%) IMPROVED BY AT LEAST ONE GRADE. IN TWO CASES, PATIENTS DETERIORATED FROM FRANKEL E TO D (WOUND HEMATOMA). 1 PATIENT HAD INSTRUMENTATION FAILURE FROM CEMENT/CAGE MIGRATION, NEEDING REVISION (FIGURE 2A-C). THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE CONFIDENCE CEMENT. THIS IMPACTED PRODUCT CAPTURES THE FOLLOWING ADVERSE EVENTS: OPERATIVE/POSTOPERATIVE COMPLICATIONS. DUROTOMY/CSF LEAK. SUPERFICIAL INFECTION. PLEURAL TEAR. PNEUMONIA. URINARY INFECTION. DEEP VENOUS THROMBOSES (DVT). PROGRESSIVE WEAKNESS DUE TO EPIDURAL HEMATOMA. REINTUBATED. STROKE. NO CHANGE/DETERIORATED OF FRANKEL GRADE. THIS REPORT IS FOR ONE (1) UNKNOWN BIOMATERIAL - CEMENT. THIS REPORT IS 1 OF 2 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571849 UNKNOWN BIOMATERIAL - CEMENT POLYMETHYLMETHACRYLATE BONE CEMENT NDN MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1