BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: UNIPLATE

    MDR report key: 12731648 · Received November 1, 2021

    Report

    Report Number
    1526439-2021-02291
    Event Type
    Injury
    Date Received
    November 1, 2021
    Report Date
    October 6, 2021
    Manufacturer
    MEDOS INTERNATIONAL SàRL CH
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THERE ARE MULTIPLE PATIENTS ALL INFORMATION IS PROVIDED IN THE ARTICLE. 510K: THIS REPORT IS FOR AN UNKNOWN UNIPLATE/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. IMPLANT DATE IS BETWEEN 2006 AND 2008. 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: ROUHOLAMIN N., PATEL A., JOHNSON B., JASANI V., (2014) SHORT TERM FOLLOW UP THE UNIPLATE DEVICE FOR USE IN ANTERIOR CERVICAL DISCECTOMY AND FUSION, EUR SPINE J VOLUME 23 (SUPPL 1), PAGES S93¿S139 (UNITED KINGDOM). THIS STUDY AIMS TO INVESTIGATE THE UNIPLATE DEVICE WHICH WAS DESIGNED TO BE USED IN ANTERIOR CERVICAL DISCECTOMY AND FUSION. BETWEEN 2006 AND 2008 35 PATIENTS UNDERWENT ACDF USING THE UNIPLATE DEVICE. 31 PATIENTS HAD SINGLE LEVEL SURGERY AND FOUR HAD 2 LEVEL SURGERY. MEAN FOLLOW UP 24 MONTHS (6¿37). THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: -1 PATIENT HAD LOSS OF LORDOSIS BUT NO SYMPTOMS. MEAN INCREASE IN LORDOSIS 3.7 DEGREES. -THERE WAS A MEAN INCREASE IN DISC HEIGHT OF 1.1 MM. THIS REPORT IS FOR AN UNKNOWN DEPUY SPINE UNIPLATE. THIS REPORT IS FOR ONE (1) UNKNOWN UNIPLATE. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1625502 UNK - PLATES: UNIPLATE APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY KWQ MEDOS INTERNATIONAL SàRL CH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention