BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 20692231 · Received November 14, 2024

    Report

    Report Number
    0009617544-2024-00149
    Event Type
    Injury
    Date Received
    November 14, 2024
    Date of Event
    January 25, 2021
    Report Date
    March 19, 2025
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: G1. H6 CODING HAS BEEN UPDATED TO REFLECT COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 0

    THE ARTICLE 'LONG-TERM RESULTS AFTER MULTILEVEL FUSION OF THE CERVICAL SPINE AND THE CERVICOTHORACIC JUNCTION: TO BRIDGE OR NOT TO BRIDGE?' IN WORLD NEUROSURGERY (2021) 148:E556-E564 WAS REVIEWED. IN THE PRESENT STUDY, WE HAVE REPORTED OUR EXPERIENCE WITH PATIENTS WITH DEGENERATIVE CERVICAL MYELOPATHY (DCM) WHO HAD UNDERGONE LAMINECTOMY AND MULTILEVEL FUSION. IN THE PRESENT RETROSPECTIVE STUDY, WE COMPARED THE INCIDENCE OF INSTRUMENT FAILURE AT THE MOST CAUDAL LEVEL OF FUSION, THE INCIDENCE OF ADJACENT SEGMENT DISEASE, AND THE REVISION RATES RESULTING FROM THESE COMPLICATIONS IN PATIENTS WITH MULTILEVEL FUSION FROM C0-C3 EXTENDING TO C7 OR T1-T3. THE PRIMARY OUTCOME MEASURE WAS RADIOLOGICALLY PROVEN COMPLICATIONS AT THE MOST CAUDAL LEVEL OF FUSION (E.G., SCREW BREAKAGE, SCREW LOOSENING, VERTEBRAL BODY FRACTURE) OR AT THE LEVEL ADJACENT TO THE MOST CAUDAL LEVEL OF FUSION THAT HAD LED TO CLINICALLY RELEVANT SEQUELAE SUCH AS MYELOPATHY OR RADICULOPATHY. POSTOPERATIVE COMPUTED TOMOGRAPHY IMAGING WAS USED TO EVALUATE THE IMPLANT POSITION AND FUSION. THE RADIOLOGICAL FINDINGS AND ALL AVAILABLE MEDICAL REPORTS WERE EVALUATED AND REVIEWED BY AN EXPERIENCED SURGEON. IN THE CASE OF ANY INCONSISTENCIES, THE IMAGING STUDIES WERE ALSO REVIEWED BY 2 OTHER EXPERIENCED SURGEONS 58 PATIENTS WERE INCLUDED IN THE PRESENT STUDY. OF THE 58 PATIENTS, 20 HAD UNDERGONE FUSION FROM C0-C3 TO C7 AND 38, FROM C0-C3 TO T1-T3. THE FOLLOWING SYSTEMS FOR FUSION WERE USED: NEON SYSTEM, 40 TIMES, AND NEON3 SYSTEM, 13 TIMES (BOTH ULRICH MEDICAL, ULM, GERMANY); VERTEX SELECT, 3 TIMES (MEDTRONIC, MINNEAPOLIS, MINNESOTA, USA); AND OASYS, 2 TIMES (STRYKER, KALAMAZOO, MICHIGAN, USA). TWICE AS MANY PATIENTS IN THE C7 GROUP (55.0%) THAN IN THE T1-T3 GROUP (28.9%) HAD DEVELOPED A GENERAL COMPLICATION. ALTOGETHER, 45% OF PATIENTS IN THE C7 GROUP HAD UNDERGONE REVISION SURGERY OR BEEN RECOMMENDED TO UNDERGO REVISION SURGERY VERSUS 5.3% IN THE TI-T3 GROUP. ONE PATIENT WAS REVISED TO ADDRESS NEUROFORAMINAL STENOSIS WITH RADICULOPATHY AT THE ADJACENT CAUDAL LEVEL OF FUSION DETECTED ONE MONTH POST-OPERATIVELY.

    Description of Event or Problem · 0

    THE ARTICLE 'LONG-TERM RESULTS AFTER MULTILEVEL FUSION OF THE CERVICAL SPINE AND THE CERVICOTHORACIC JUNCTION: TO BRIDGE OR NOT TO BRIDGE?' IN WORLD NEUROSURGERY (2021) 148:E556-E564 WAS REVIEWED. IN THE PRESENT STUDY, WE HAVE REPORTED OUR EXPERIENCE WITH PATIENTS WITH DEGENERATIVE CERVICAL MYELOPATHY (DCM) WHO HAD UNDERGONE LAMINECTOMY AND MULTILEVEL FUSION. IN THE PRESENT RETROSPECTIVE STUDY, WE COMPARED THE INCIDENCE OF INSTRUMENT FAILURE AT THE MOST CAUDAL LEVEL OF FUSION, THE INCIDENCE OF ADJACENT SEGMENT DISEASE, AND THE REVISION RATES RESULTING FROM THESE COMPLICATIONS IN PATIENTS WITH MULTILEVEL FUSION FROM C0-C3 EXTENDING TO C7 OR T1-T3. THE PRIMARY OUTCOME MEASURE WAS RADIOLOGICALLY PROVEN COMPLICATIONS AT THE MOST CAUDAL LEVEL OF FUSION (E.G., SCREW BREAKAGE, SCREW LOOSENING, VERTEBRAL BODY FRACTURE) OR AT THE LEVEL ADJACENT TO THE MOST CAUDAL LEVEL OF FUSION THAT HAD LED TO CLINICALLY RELEVANT SEQUELAE SUCH AS MYELOPATHY OR RADICULOPATHY. POSTOPERATIVE COMPUTED TOMOGRAPHY IMAGING WAS USED TO EVALUATE THE IMPLANT POSITION AND FUSION. THE RADIOLOGICAL FINDINGS AND ALL AVAILABLE MEDICAL REPORTS WERE EVALUATED AND REVIEWED BY AN EXPERIENCED SURGEON. IN THE CASE OF ANY INCONSISTENCIES, THE IMAGING STUDIES WERE ALSO REVIEWED BY 2 OTHER EXPERIENCED SURGEONS 58 PATIENTS WERE INCLUDED IN THE PRESENT STUDY. OF THE 58 PATIENTS, 20 HAD UNDERGONE FUSION FROM C0-C3 TO C7 AND 38, FROM C0-C3 TO T1-T3. THE FOLLOWING SYSTEMS FOR FUSION WERE USED: NEON SYSTEM, 40 TIMES, AND NEON3 SYSTEM, 13 TIMES (BOTH ULRICH MEDICAL, ULM, GERMANY); VERTEX SELECT, 3 TIMES (MEDTRONIC, MINNEAPOLIS, MINNESOTA, USA); AND OASYS, 2 TIMES (STRYKER, KALAMAZOO, MICHIGAN, USA). TWICE AS MANY PATIENTS IN THE C7 GROUP (55.0%) THAN IN THE T1-T3 GROUP (28.9%) HAD DEVELOPED A GENERAL COMPLICATION. ALTOGETHER, 45% OF PATIENTS IN THE C7 GROUP HAD UNDERGONE REVISION SURGERY OR BEEN RECOMMENDED TO UNDERGO REVISION SURGERY VERSUS 5.3% IN THE TI-T3 GROUP. ONE PATIENT WAS REVISED TO ADDRESS NEUROFORAMINAL STENOSIS WITH RADICULOPATHY AT THE ADJACENT CAUDAL LEVEL OF FUSION DETECTED ONE MONTH POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186636 UNKNOWN_SPINE_PRODUCT POSTERIOR CERVICAL SCREW SYSTEM NKG STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention