BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - CONSTRUCTS: USS II

    MDR report key: 11886622 · Received May 26, 2021

    Report

    Report Number
    8030965-2021-04306
    Event Type
    Injury
    Date Received
    May 26, 2021
    Report Date
    April 28, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). THIS REPORT IS FOR AN UNK - CONSTRUCTS: USS II/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 AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. THE PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YANG P, ET AL. (2020), TREATMENT OF THORACIC OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT WITH ONE-STAGE 360 DEGREE CIRCUMFERENTIAL DECOMPRESSION ASSISTED BY PIEZO SURGERY, JOURNAL OF INVESTIGATIVE SURGERY, PAGES 1-9 (CHINA) THIS STUDY AIMS TO EVALUATE THE SAFETY AND CLINICAL EFFICACY OF ONE-STAGE 360-DEGREE CIRCULAR DECOMPRESSION FOR THORACIC OSSIFICATION OF THE POSTERIOR LONGITUDINAL LIGAMENT (TOPLL) ASSISTED BY PIEZO SURGERY. BETWEEN AUGUST 2016 AND FEBRUARY 2019, 36 PATIENTS WITH THORACIC OSSIFICATION OF POSTERIOR LONGITUDINAL LIGAMENT SURGICALLY TREATED BY ONE-STAGE 360-DEGREE CIRCUMFERENTIAL DECOMPRESSION ASSISTED BY PIEZO SURGERY WERE INCLUDED IN THE STUDY. THERE WERE (13 FEMALE AND 23 MALE) WITH MEAN AGE OF 52.8 YEARS OLD (RANGE, 27¿80 YEARS). THE SURGICAL DEVICES USED FOR THIS STUDY WERE A PIEZO SURGERY MEDICAL DEVICE WITH DIFFERENT TIPS, A NEUROELECTROPHYSIOLOGICAL MONITORING INSTRUMENT AND AN INTERNAL FIXATION INSTRUMENT. FOR THE INTERNAL FIXATION INSTRUMENTS, ALL PATIENTS WERE IMPLANTED WITH AUTOGENOUS BONE FRAGMENTS INTO THE INTERVERTEBRAL SPACE USING AN UNKNOWN SYNTHES USS II POLY A PEDICLE SCREW SYSTEM. INTRAOPERATIVE AND POSTOPERATIVE COMPLICATIONS WERE OBSERVED AND SUBSEQUENTLY TREATED. THE FOLLOW-UP WAS ARRANGED AT 1-, 3-, 6-, 12 MONTHS AFTER THE OPERATION, AND FINALLY, REEXAMINED EVERY YEAR. THE DURATION OF ONSET WAS 7.4 MONTHS WITH A FOLLOW-UP PERIOD OF 23.8 MONTHS. COMPLICATIONS WERE REPORTED: 7 PATIENTS HAD CEREBROSPINAL FLUID LEAKAGE OF WHICH 3 PATIENTS WERE COMPLICATED WITH OSSIFICATION OF LIGAMENTUM FLAVUM, AND DURAL TEAR OCCURRED DURING LAMINECTOMY¿THE OTHER PATIENTS DEVELOPED OPLL DURAL ADHESION AND VENTRAL TEAR OF DURAL SAC DURING SEPARATION. 6 PATIENTS HAD TEMPORARY LOWER LIMB MYODYNAMIA OF WHICH 4 PATIENTS RECOVERED TO THE PREOPERATIVE LEVEL WITHIN ONE WEEK AFTER THE OPERATION, AND THE OTHER 2 PATIENTS RECOVERED TO THE PREOPERATIVE LEVEL HALF A YEAR AFTER THE OPERATION. 2 PATIENTS HAD SUSPECTED WOUND INFECTION WHO DEVELOPED A HIGH FEVER AND CHILLED 1 WEEK AFTER THE OPERATION. INFECTION INDEX SCREENING AND WOUND MRI EXAMINATION WERE SUBSEQUENTLY PERFORMED FOR THESE PATIENTS. THE BODY TEMPERATURE AND INFECTION INDEX RETURNED TO NORMAL AFTER TWO WEEKS OF VANCOMYCIN PLUS SHUPU. 5 PATIENTS HAD SEVERE INTERCOSTAL NEURALGIA, WITH A VAS SCORE OF MORE THAN 7 AND THE POSTOPERATIVE COMPLICATIONS WERE ONLY RELIEVED AFTER INTERCOSTAL NERVE BLOCKING TREATMENT. THIS REPORT IS FOR THE UNKNOWN SYNTHES USS II POLY A PEDICLE SCREW SYSTEM. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR (1) UNK - CONSTRUCTS: USS II. THIS REPORT IS 1 OF 1 (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778897 UNK - CONSTRUCTS: USS II ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION MNH SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention