BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL

    MDR report key: 8471499 · Received April 1, 2019

    Report

    Report Number
    8030965-2019-62402
    Event Type
    Injury
    Date Received
    April 1, 2019
    Report Date
    March 7, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    ODP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    510K: THIS REPORT IS FOR AN UNKNOWN CAGE/PLATE ZERO-PROFILE DEVICE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. 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. 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: ZHANG L ET AL (2018), OUTCOME EVALUATION OF ZERO-PROFILE DEVICE USED FOR SINGLE-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION WITH OSTEOPOROSIS COMPARED WITHOUT OSTEOPOROSIS: A MINIMUM THREE-YEAR FOLLOW-UP STUDY. WORLD NEUROSURGERY. PAGES E1-E9. (CHINA). THE AIM OF THE PRESENT STUDY WAS TO COMPARE THE MID-TERM EFFICACY AND SAFETY OF THE ZERO-PROFILE DEVICE IN THE TREATMENT OF SINGLE-LEVEL CERVICAL DEGENERATIVE DISC DISEASE (CDDD) IN PATIENTS WITH AND WITHOUT OSTEOPOROSIS AND DETERMINE WHETHER THE ZERO- PROFILE DEVICE IS SUITABLE FOR SINGLE-LEVEL CDDD IN THE PRESENCE OF OSTEOPOROSIS. BETWEEN DECEMBER 2010 TO DECEMBER 2014, 42 PATIENTS WITH SINGLE-LEVEL CDDD WHO UNDERWENT ANTERIOR CERVICAL DISCECTOMY AND FUSION USING AN UNKNOWN SYNTHES ZERO-PROFILE DEVICE WERE INCLUDED IN THE PRESENT STUDY. THE ZERO-PROFILE DEVICE CONSISTS OF CONSISTS OF A SMALL TITANIUM ALLOY PLATE, A POLYETHER ETHER KETONE POLYMER CAGE, AND 4 SCREWS FOR INTERNAL FIXATION. 42 PATIENTS WERE INITIALLY INCLUDED, HOWEVER, 4 PATIENTS WERE LOST TO FOLLOW-UP. 38 PATIENTS REMAINED AND WERE AVAILABLE FOR ANALYSIS. THE PATIENTS WERE DIVIDED INTO 2 GROUPS: THE OSTEOPOROSIS GROUP (GROUP A) AND THE NO-OSTEOPOROSIS GROUP (GROUP B). 18 WERE IN GROUP A (3 MEN AND 15 WOMEN; AGE RANGE, 60 TO76 YEARS; MEAN AGE, 66.9), AND 20 WERE IN GROUP B (8 MEN AND 12 WOMEN; AGE RANGE, 60 TO 78 YEARS; MEAN AGE, 67.3 YEARS). ALL THE PATIENTS WORE A PHILADELPHIA COLLAR FOR 3 MONTHS POSTOPERATIVELY. OSTEOPOROSIS TREATMENT, INCLUDING ORAL ACTIVATED VITAMIN D 800 IU/DAY, CALCIUM 1200 MG/DAY, AND BISPHOSPHONATES, WERE TAKEN BY ALL PATIENTS IN GROUP A AFTER THEY HAD UNDERGONE ACDF. THEIR SERUM CALCIUM LEVEL WAS CHECKED MONTHLY. THE INCIDENCE OF DYSPHAGIA WAS EVALUATED USING THE GRADING SYSTEM REPORTED BY BAZAZ ET AL., DEFINED AS NONE, MILD, MODERATE, AND SEVERE AT 1 AND 3 MONTHS AND THE FINAL FOLLOW-UP VISIT POSTOPERATIVELY. THE MEAN FOLLOW-UP TIME WAS 40.1 +/- 3.2 MONTHS IN GROUP A AND 41.5 +/- 3.1 MONTHS IN GROUP B. COMPLICATIONS WERE REPORTED AS FOLLOWS: GROUP A: 1 PATIENT COMPLAINED OF MILD DYSPHAGIA. 1 PATIENT COMPLAINED OF MODERATE DYSPHAGIA. 2 PATIENTS HAD CAGE SUBSIDENCE. GROUP B: 2 PATIENTS HAD POSTOPERATIVE CERVICAL SOFT TISSUE SWELLING. 2 PATIENTS COMPLAINED OF MILD DYSPHAGIA. 1 PATIENT COMPLAINED OF MODERATE DYSPHAGIA. 2 PATIENTS HAD CAGE SUBSIDENCE. THIS REPORT CAPTURES THE REPORTED EVENT OF CAGE SUBSIDENCE. THIS REPORT IS FOR SYNTHES UNKNOWN CAGE/PLATE ZERO-PROFILE DEVICE. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264888 INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention