BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: SPINE

    MDR report key: 10612622 · Received October 1, 2020

    Report

    Report Number
    8030965-2020-07587
    Event Type
    Injury
    Date Received
    October 1, 2020
    Report Date
    September 8, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    ODP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN SYNAPSE MINI PLATE/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI 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: YEH, K.T. ET AL. (2015), LAMINOPLASTY INSTEAD OF LAMINECTOMY AS A DECOMPRESSION METHOD IN POSTERIOR INSTRUMENTED FUSION FOR DEGENERATIVE CERVICAL KYPHOSIS WITH STENOSIS, JOURNAL OF ORTHOPAEDIC SURGERY AND RESEARCH VOL. 10 (138), PAGES 1-6 (TAIWAN). DOI: 10.1186/S13018-015-0280-Y. THIS STUDY PRESENTS THE SURGICAL OUTCOMES OF LAMINOPLASTY, INSTEAD OF LAMINECTOMY, AS A DECOMPRESSION METHOD APPLIED IN POSTERIOR INSTRUMENTED FUSION FOR DEGENERATIVE CERVICAL KYPHOSIS WITH STENOSIS (DCKS). BETWEEN 2008 AND 2011, A TOTAL OF 20 PATIENTS (10 MALES AND 10 FEMALES) WITH A MEAN AGE AT THE TIME OF SURGERY WAS 67.6 ± 15.2 YEARS UNDERWENT ONE-STAGE ANTERIOR AND POSTERIOR DECOMPRESSION AND FUSION PROCEDURE USING TITANIUM MINIPLATES (AO/ASIF MINIPLATE SYSTEM, SYNTHES, USA) AND A PEDICLE SCREW-ROD SYSTEM (SYNAPSE SPINE SYSTEM, DEPUY SYNTHES, USA). THE FOLLOW-UP DURATION WAS AT LEAST 24 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 PATIENT EXHIBITED A SUPERFICIAL POSTERIOR WOUND INFECTION AND RECOVERED AFTER 2 WEEKS OF ANTIBIOTICS TREATMENT. THIS IS REPORT 3 OF 3 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNTHES TITANIUM MINIPLATES (AO/ASIF MINIPLATE SYSTEM, SYNTHES, USA) AND A PEDICLE SCREW-ROD SYSTEM (SYNAPSE SPINE SYSTEM, DEPUY SYNTHES, USA). THE FOLLOW-UP DURATION WAS AT LEAST 24 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078466 UNK - PLATES: SPINE INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, CERVICAL ODP OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention