BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-ARM IMAGING SYSTEM

    MDR report key: 12860906 · Received November 23, 2021

    Report

    Report Number
    3004785967-2021-01310
    Event Type
    Injury
    Date Received
    November 23, 2021
    Date of Event
    June 15, 2021
    Report Date
    November 23, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC (LITTLETON)
    Product Code
    OXO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY. THIS VALUE REFLECTS THE AVERAGE AGE OF THE PATIENTS WHO UNDERWENT THE POSTERIOR WEDGE OSTEOTOMY AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS WHO UNDERWENT THE POSTERIOR WEDGE OSTEOTOMY AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE PROVIDED IS THE ACCEPTED DATE. THE ARTICLE CITATION IS INCLUDED. THE SERIAL NUMBER WAS NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. NO 510K PROVIDED AS SYSTEM IS UNKNOWN. NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. DEVICE MANUFACTURING DATE IS UNAVAILABLE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    LI, BO, ET AL. ¿POSTERIOR WEDGE OSTEOTOMY ASSISTED BY O-ARM NAVIGATION FOR TREATING ANKYLOSING SPONDYLITIS WITH THORACOLUMBAR FRACTURES: AN EARLY CLINICAL EVALUATION.¿ ANNALS OF PALLIATIVE MEDICINE, 2021, HTTPS://DOI.ORG/10.21037/APM-21-1286. SUMMARY BACKGROUND: TO EXPLORE THE FEASIBILITY AND EFFICIENCY OF POSTERIOR WEDGE OSTEOTOMY ASSISTED BY O-ARM NAVIGATION TREATMENT OF ANKYLOSING SPONDYLITIS (AS) PATIENTS WITH THORACOLUMBAR FRACTURE. METHODS: THIS IS A CASE SERIES STUDY. A TOTAL OF 16 CASES OF AS ACCOMPANIED BY THORACOLUMBAR FRACTURES FROM JANUARY 2012 TO JULY 2015 WERE RETROSPECTIVELY ANALYZED. ALL PATIENTS UNDERWENT ¿POSTERIOR WEDGE OSTEOTOMY ASSISTED BY O-ARM NAVIGATION¿. THE OPERATION TIME, BLOOD LOSS VOLUME, PREOPERATIVE AND POSTOPERATIVE VISUAL ANALOGUE SCALE (VAS), AMERICAN SPINAL INJURY ASSOCIATION (ASIA) CLASSIFICATION, AND SPINAL IMAGING PARAMETERS [COBB ANGLE, C7 PLUMB LINE (C7PL), AND JAW-BROW ANGLE] WERE COLLECTED AND ANALYZED. RESULTS: THE OPERATIVE TIME CONSUMPTION WAS 120¿350 MINS AND THE INTRA-OPERATIVE BLOOD LOSS VOLUME WAS 200¿800 ML. NO OBVIOUS POSTOPERATIVE COMPLICATIONS OCCURRED IN ANY PARTICIPANTS. THE BACK PAIN OF ALL PARTICIPANTS WAS RELIEVED, AND THE NEUROLOGICAL FUNCTIONS OF EIGHT PARTICIPANTS WITH SPINAL CORD INJURY (SCI) WERE RECOVERED IN VARYING DEGREES EXCEPT FOR ONE PATIENT WITH SEVERE SCI. THE SPINAL DEFORMITIES OF THE PARTICIPANTS WERE CORRECTED TO VARYING DEGREES. THE FRACTURE SITES OF 16 PARTICIPANTS WERE ALL HEALED, AND THERE WAS NO LOOSENING OR DETACHMENT OF INTERNAL FIXATION DURING THE 6-MONTH FOLLOW-UP PERIOD. CONCLUSIONS: POSTERIOR WEDGE OSTEOTOMY ASSISTED BY O-ARM NAVIGATION WAS SHOWN TO BE A SAFE AND EFFECTIVE METHOD TO TREAT AS ACCOMPANIED BY THORACOLUMBAR FRACTURES. THIS TREATMENT STRATEGY CAN ACCURATELY DECOMPRESS AND REDUCE THE FRACTURE AND SIGNIFICANTLY CORRECT THE KYPHOSIS, WITH GOOD SURGICAL EFFECT. REPORTED EVENTS: SIXTEEN PATIENTS WITH ANKYLOSING SPONDYLITIS DUE TO THORACOLUMBAR FRACTURE UNDERWENT A POSTERIOR WEDGE OSTEOTOMY THAT WAS ASSISTED BY AN IMAGING SYSTEM. IT WAS REPORTED THAT PATIENTS THAT BLED OVER 1,500 ML AND HAD A SURGICAL TIME OVER 3 HOURS WERE TREATED WITH ANTIBIOTICS FOR ONE TO TWO DAYS AFTER THE SURGERY. PATIENTS WITH SPINAL CORD INJURY(SCI) WERE TREATED WITH DRUGS TO ADDRESS DEHYDRATION AND PROVIDE NERVE NUTRITION. IT WAS ALSO NOTED THAT ONE PATIENT HAD A LONGER OPERATION TIME AND THEIR BLEEDING VOLUME REACHED 800 ML. THIS CAUSED THE SITE TO PERFORM AN AUTOLOGOUS BLOOD TRANSFUSION. ANOTHER PATIENT WAS EXPERIENCED A SCI DURING THE OPERATION. AFTER THE SCREW WAS REPLACED AND POSTOPERATIVE HORMONE APPLICATION, THE PATIENT HAD NO NEUROLOGICAL DAMAGE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759831 O-ARM IMAGING SYSTEM IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, M OXO MEDTRONIC NAVIGATION, INC (LITTLETON) UNK_OARM_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Required Intervention| O