BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 12733929 · Received November 1, 2021

    Report

    Report Number
    1625507-2021-00345
    Event Type
    Injury
    Date Received
    November 1, 2021
    Report Date
    November 1, 2021
    Manufacturer
    MDT POWERED SURGICAL SOLUTIONS
    Product Code
    HBE
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO CONCLUSION CAN BE DRAWN. NO EVALUATION WAS PERFORMED, AS THESE DEVICES WERE NOT RETURNED. IF THESE DEVICES WERE 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 A JOURNAL OF NEUROSURG SPINE 34:573¿579, 2021, ARTICLE NAME: MICROENDOSCOPIC DECOMPRESSION FOR LUMBAR SPINAL STENOSIS CAUSED BY FACET-JOINT CYSTS: A NOVEL TECHNIQUE WITH A CYST-DYEING PROTOCOL AND COHORT COMPARISON STUDY; THAT A HIGH-SPEED DRILL WITH A LONG, CURVED ENDOSCOPIC BIT (MIDAS REX, MEDTRONIC) WAS USED DURING A LAMINOTOMY PROCEDURE. MICROENDOSCOPIC LAMINOTOMY (MEL) WAS PERFORMED IN 45 PATIENTS WITH INTRASPINAL CANAL STENOSIS, AND MICROENDOSCOPIC DECOMPRESSION (MED) OF THE SPINE WAS PERFORMED IN 3 PATIENTS WITH FORAMINAL STENOSIS WHICH WERE PERFORMED BY 3 ENDOSCOPIC SPINE SURGEONS. FOR THE MEL, A SKIN INCISION OF APPROXIMATELY 16 MM IN LENGTH WAS MADE TO TARGET THE INTERLAMINAR SPACE AND A SERIAL TUBAL DILATORS OF THE METRX ENDOSCOPIC SYSTEM (MEDTRONIC SOFAMOR DANEK) WERE INSERTED THROUGH THE INCISION. DECOMPRESSION OF THE BILATERAL LATERAL RECESS WAS ACHIEVED VIA A MEDIAL TRUMPET FACETECTOMY AND THE INTEGRITY OF THE FACET JOINT WAS PRESERVED USING THE CURVED KERRISON RONGEURS. REGARDING PERIOPERATIVE COMPLICATIONS, A DURAL TEAR WAS OBSERVED IN 4 PATIENTS BUT THESE TEARS DID NOT AFFECT THE POSTOPERATIVE COURSE IN ANY OF THE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1628055 UNKNOWN DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE HBE MDT POWERED SURGICAL SOLUTIONS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other UNKNOWN TOOL (L/N: UNKNOWN)