BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN MOTOR

    MDR report key: 12934370 · Received December 6, 2021

    Report

    Report Number
    1625507-2021-00373
    Event Type
    Injury
    Date Received
    December 6, 2021
    Report Date
    December 6, 2021
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBB
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO CONCLUSION CAN BE DRAWN. NO EVALUATION WAS PERFORMED, AS THE DEVICE WAS NOT RETURNED. IF THE DEVICE IS RETURNED IN THE FUTURE, PRODUCT ANALYSIS MAY BE PERFORMED. THE DEVICE USER MANUAL WARNINGS SECTION INCLUDES INSTRUCTIONS TO CHECK THE DEVICE FOR DAMAGE BEFORE USE. IF DAMAGE IS FOUND, THE DEVICE SHOULD NOT BE USED. WE WILL CONTINUE TO TRACK AND TREND THIS COMPLAINT TYPE. PMA / 510(K) #: NO INFORMATION AVAILABLE ON DEVICE TO CONFIRM APPLICABLE 510(K). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED IN THE JOURNAL OF CLINICAL NEUROSCIENCE 93 (2021) 75-81, ARTICLE NAME: INTRAOPERATIVE COMPUTED TOMOGRAPHY-GUIDED NAVIGATION VERSUS FLUOROSCOPY FOR SINGLE-POSITION SURGERY AFTER LATERAL LUMBAR INTERBODY FUSION; THAT A NAVIGATION-ASSISTED HIGH-SPEED DRILL STEALTH MIDAS SYSTEM WAS USED AND DOCKED AT THE OPTIMAL ENTRY POINT AFTER A 2-3CM SKIN INCISION HAD BEEN MADE. AFTER MAKING THE HOLE FOR THE PERCUTANEOUS PEDICLE SCREW, THREADING WAS CREATED WHICH WERE SUBSEQUENTLY INSERTED WHILE MONITORING THE CAD MODEL ON THE CT NAVIGATION SYSTEM. A TOTAL OF 99 PATIENTS (62 MALES AND 37 FEMALES) WERE INCLUDED IN THE STUDY. THEY CONCLUDED THAT THERE WAS NO SIGNIFICANT DIFFERENCE IN ACCURACY BETWEEN FLUOROSCOPY AND INTRAOPERATIVE CT NAVIGATION, SUGGESTING THAT ONE OF THE ADVANTAGES OF LATERAL SINGLE POSITION SURGERY USING INTRAOPERATIVE CT NAVIGATION RATHER THAN FLUOROSCOPY MAY BE THE POSSIBILITY OF PREVENTING THE OCCURRENCE OF FACET JOINT VIOLATION. IT WAS REPORTED THAT THERE WAS NO DIFFERENCE IN IMPLANT-RELATED COMPLICATIONS, AND THE FLUOROSCOPY TECHNIQUE WAS SUPERIOR ONLY IN TERMS OF AVERAGE OPERATION TIME. IT WAS ALSO REPORTED THAT 28 PATIENTS HAD POSTOPERATIVE THIGH SYMPTOMS; OF THESE PATIENTS, 12 REPORTED MOTOR WEAKNESS AND 20 REPORTED ANTERIOR THIGH PAIN AND NUMBNESS. ALSO, FIVE PATIENTS HAD POSTOPERATIVE MOTOR WEAKNESS AND SENSORY IMPAIRMENT. THREE PATIENTS HAD REOPERATION DUE TO IMPLANT-RELATED COMPLICATIONS SUCH AS PERCUTANEOUS PEDICLE SCREW DEVIATION AND CAGE MALPOSITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1832350 UNKNOWN MOTOR MOTOR, DRILL, PNEUMATIC HBB MDT POWERED SURGICAL SOLUTIONS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other