BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: SKYLINE PLATE/SCREWS

    MDR report key: 19459621 · Received June 4, 2024

    Report

    Report Number
    1526439-2024-01626
    Event Type
    Injury
    Date Received
    June 4, 2024
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H11 ADDITIONAL NARRATIVE: D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNKNOWN CONSTRUCTS: SKYLINE PLATE/SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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. H6 COMPONENT CODE: G07002 (APPROPRIATE TERM/CODE NOT AVAILABLE) USED TO CAPTURE NO FINDINGS AVAILABLE DUE TO NO PRODUCT RETURNED. 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YNAG, H. ET AL (2018), ANTERIOR CONTROLLABLE ANTEDISPLACEMENT FUSION AS A CHOICE FOR OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT AND DEGENERATIVE KYPHOSIS AND STENOSIS: POSTOPERATIVE MORPHOLOGY OF DURA MATER AND PROBABILITY ANALYSIS OF EPIDURAL HEMATOMA BASED ON 63 PATIENTS, WORLD NEUROSURGERY XX(XX), PAGES E1-E8 (CHINA). THE AUTHORS SOUGHT TO STUDY THE POSTOPERATIVE MORPHOLOGY OF THE DURA MATER AND ANALYZED THE PROBABILITY OF EPIDURAL HEMATOMA (EH) AFTER ANTERIOR CONTROLLABLE ANTEDISPLACEMENT AND FUSION (ACAF). BETWEEN JUNE 2016 TO DECEMBER 2017, A TOTAL OF 63 PATIENTS WERE INCLUDED IN THE STUDY. THESE PATIENTS HAD SYMPTOMS OF CERVICAL MYELOPATHY DUE TO OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT (OPLL) AND DEGENERATIVE KYPHOSIS AND STENOSIS (DKS) AND UNDERWENT ANTERIOR CONTROLLABLE ANTEDISPLACEMENT FUSION (ACAF) USING THE SKYLINE ANTERIOR CERVICAL PLATE SYSTEM WITH CAGE (DEPUY SYNTHES). OF THE 63 PATIENTS, 39 HAD OPLL (24 MALE AND 15 FEMALE) WITH A MEAN AGE OF 59.2 YEARS, AND 24 HAD DKS (13 MALE AND 11 FEMALE) WITH A MEAN AGE OF 53.7 YEARS). ALL THE PATIENTS WERE FOLLOWED UP FOR 3-18 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: OPLL GROUP (N=1) NERVE INJURY (N=1) CEREBROSPINAL FLUID LEAKAGE THIS REPORT IS FOR AN UNKNOWN SYNTHES SKYLINE ANTERIOR CERVICAL PLATE SYSTEM WITH CAGE. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202692 UNK - CONSTRUCTS: SKYLINE PLATE/SCREWS ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention