BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: ZERO-P

    MDR report key: 11665927 · Received April 14, 2021

    Report

    Report Number
    8030965-2021-02902
    Event Type
    Injury
    Date Received
    April 14, 2021
    Report Date
    March 18, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN ZERO-PROFILE SPACER/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. 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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: HU X, ET AL (2021), CERVICAL DISC ARTHROPLASTY VERSUS ANTERIOR CERVICAL DISCECTOMY AND FUSION FOR THE TREATMENT OF SINGLE-LEVEL DISC DEGENERATIVE DISEASE WITH PREOPERATIVE REVERSIBLE KYPHOSIS, CLINICAL NEUROLOGY AND NEUROSURGERY, VOLUME 202, PAGE 1-7, (CHINA). THE PURPOSE OF THIS STUDY WAS TO EVALUATE AND COMPARE THE CLINICAL AND RADIOLOGICAL OUTCOMES OF SINGLE-LEVEL CERVICAL DISC ARTHROPLASTY (CDA) WITH PRESTIGE-LP DISC (MEDTRONIC SOFAMOR DANEK, MEMPHIS, TN) AND SINGLE-LEVEL ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) WITH ZERO-P SPACER (SYNTHES GMBH SWITZERLAND, OBERDORF, SWITZERLAND) IN THE PATIENT WITH PREOPERATIVE REVERSIBLE KYPHOSIS. FROM JANUARY 2014 TO MARCH 2018, 82 PATIENTS WHO UNDERWENT SINGLE LEVEL CDA WITH PRESTIGE-LP DISC AND SINGLE-LEVEL ACDF WITH UNKNOWN SYNTHES ZERO-P SPACER WERE ENROLLED IN THE STUDY, 2 OF WHICH WERE EXCLUDED FOR POOR IMAGING QUALITY OR INCOMPLETE DATA. IN THE FINALLY ANALYSIS, 38 PATIENTS WERE INCLUDED IN THE CDA GROUP WHILE 42 PATIENTS (15 MALES & 27 FEMALES WITH A MEAN AGE OF 43.9+/-7.8 YEARS) WERE INCLUDED IN THE ACDF GROUP. ALL PATIENTS IN THE ACDF GROUP WERE IMPLANTED WITH AN UNKNOWN SYNTHES ZERO-P SPACER. CLINICAL AND RADIOLOGICAL DATA WERE OBTAINED PREOPERATIVELY AND POSTOPERATIVELY AT 6, 12 MONTHS AND THE LAST FOLLOW-UP. THE AVERAGE FOLLOW-UP IN THE ACDF GROUP WAS 37.6 MONTHS, RANGING FROM 18 TO 61 MONTHS. COMPLICATIONS WERE REPORTED AS FOLLOWS: 9 PATIENTS HAD POSTOPERATIVE TRANSIENT DYSPHAGIA. 12 PATIENTS HAD KYPHOSIS AT THE LAST FOLLOW-UP. 5 PATIENTS (1 CASE AT THE INFERIOR LEVEL, 4 CASES AT THE SUPERIOR LEVEL) DEVELOPED ADJACENT SEGMENT DEGENERATION AT THE LAST FOLLOW-UP. THIS REPORT IS FOR THE UNKNOWN SYNTHES ZERO-PROFILE SPACER. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564815 UNK - CONSTRUCTS: ZERO-P INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention