BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: ZERO-P

    MDR report key: 11664491 · Received April 14, 2021

    Report

    Report Number
    8030965-2021-02893
    Event Type
    Injury
    Date Received
    April 14, 2021
    Report Date
    March 17, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    OVE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SPINE ZERO-P SCREW/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.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SUN B., ET AL (2020) APPLICATION OF ZERO-PROFILE SPACER IN THE TREATMENT OF THREE-LEVEL CERVICAL SPONDYLOTIC MYELOPATHY, SPINE VOLUME 45,NUMBER 8 PAGES 504¿511 ((B)(6)). THIS STUDY AIMS TO COMPARE COLLECTED CASES OF THREE CONSECUTIVE LEVELS OF ACDF USING ONLY ZERO-P COMPARING ALL DATA OF THESE CASES TO THAT OF CASES THAT UNDERWENT THE SAME SURGICAL PROCEDURE WITH ANTERIOR PLATE AND CAGES. CASES THAT RECEIVED 3-LEVEL CONSECUTIVE ACDF FOR CSM WERE RETROSPECTIVELY COLLECTED. A TOTAL 61 PATIENTS (40 MALES AND 21 FEMALES) WERE INCLUDED IN THE STUDY. ZERO-P (ZP GROUP) HAD 27 CASES (15 MALES, 12 FEMALES) AGE 54.77.6 YEARS, AND 34 CASES (25 MALES, 9 FEMALES) AGE 56.47.5 YEARS IN THE PREBENT LOCKING PLATE AND CAGES (PC GROUP). PATIENTS WERE FOLLOWED UP FOR FIVE YEARS. HE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: AT/AFTER 3-YEAR FOLLOW-UP BETWEEN TWO GROUPS. LOC OF LORDOSIS IN ZP GROUP WAS HIGHER THAN IN PC GROUP SINCE 3-YEAR FOLLOW-UP (P<0.05)WERE DETECTED. AT FINAL FOLLOW-UP, IT WAS 48.13-44.90% IN ZP AND 14.01-25.76% IN PC GROUP (P <0.05). DISC HEIGHT AND CERVICAL LORDOSIS (C2-7 COBB ANGLE) WERE WELL RESTORED AFTER OPERATIONS, BUT LOST IN BOTH GROUPS DURING FOLLOW-UP. RADIOLOGIC FUSION WAS OBSERVED IN 75 OF 81 LEVELS IN ZP GROUP. DYSPHAGIA EXPERIENCED BY 11 OF 27 PATIENTS IN ZP GROUP AT 48 HOURS POSTOPERATIVELY. AT THE 6-MONTH FOLLOW-UP VISIT, FROM DYSPHAGIA ASD WAS DETECTED IN 7 PATIENTS, 1 IN ZP GROUP. AT THE FINAL FOLLOW UP, 11 LEVELS OF 7 PATIENTS WITH CAGE SUBSIDENCE WERE OBSERVED IN ZP GROUP SCREW MIGRATION WAS FOUND IN A (B)(6) WOMAN WITH TWO LEVELS INVOLVED FROM ZP GROUP AT 2-YEAR FOLLOW-UP. THIS REPORT IS FOR AN UNKNOWN SYNTHES SPINE ZERO-P SCREW. IT CAPTURES THE REPORTED EVENT OF SCREW MIGRATION WHICH WAS FOUND IN A (B)(6) WOMAN WITH TWO LEVELS INVOLVED FROM ZP GROUP AT 2-YEAR FOLLOW-UP. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562696 UNK - SCREWS: ZERO-P INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention