BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 20692280 · Received November 14, 2024

    Report

    Report Number
    0009617544-2024-00155
    Event Type
    Malfunction
    Date Received
    November 14, 2024
    Date of Event
    January 13, 2010
    Report Date
    March 19, 2025
    Manufacturer
    STRYKER SPINE-US
    Product Code
    NKG
    Product Problem
    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 'COMPARISON BETWEEN ANTERIOR AND POSTERIOR DECOMPRESSION WITH INSTRUMENTATION FOR CERVICAL SPONDYLOTIC MYELOPATHY: SAGITTAL ALIGNMENT AND CLINICAL OUTCOME' IN NEUROSURGERY FOCUS, VOLUME 28, MARCH 2010 WAS REVIEWED. THE AIM OF THE PRESENT STUDY WAS TO COMPARE THE EFFICACY OF MULTI-LEVEL ANTERIOR OR POSTERIOR DECOMPRESSIVE SURGERY OF THE CERVICAL SPINE WITH INSTRUMENTATION, FOCUSING ESPECIALLY ON SAGITTAL ALIGNMENT. 48 PATIENTS WERE INCLUDED IN THE STUDY: 24 IN THE ANTERIOR GROUP, AND 24 IN THE POSTERIOR GROUP. THESE PATIENTS SUFFERED FROM DEGENERATIVE CERVICAL SPINAL CANAL STENOSIS, AND UNDERWENT DECOMPRESSIVE SURGERY OF THE CERVICAL SPINE SOMETIME BETWEEN 1998 AND 2008. THE PRIMARY SYMPTOM IN ALL PATIENTS WAS MYELOPATHY (CSM). IN TOTAL, THERE WERE 29 MEN (12 ANTERIOR GROUP, 17 POSTERIOR GROUP) AND 19 WOMEN (12 ANTERIOR GROUP, 7 POSTERIOR GROUP) WHO UNDERWENT OPERATIONS. THE PATIENTS¿ AGES AT OPERATION RANGED FROM 45 TO 84 YEARS OLD, WITH A MEAN OF 64 YEARS. THE POSTERIOR GROUP (66.2 ± 8.8 YEARS) WAS SIGNIFICANTLY OLDER THAN THE ANTERIOR GROUP (60.4 ± 9.9 YEARS; P = 0.045). IN THE ANTERIOR GROUP, A 1¿2-LEVEL CORPECTOMY WAS FOLLOWED BY PLACEMENT OF A NON-STRYKER EXPANDABLE TITANIUM CAGE. IN THE POSTERIOR GROUP, A MULTILEVEL LAMINECTOMY AND POSTERIOR INSTRUMENTATION USING LATERAL MASS SCREWS WAS PERFORMED. POSTOPERATIVE RADIOGRAPHY AND CLINICAL EXAMINATIONS WERE PERFORMED AFTER 1 WEEK, 12 MONTHS, AND AT LAST FOLLOW-UP (RANGE 15¿112 MONTHS, MEAN 33 MONTHS). THE RADIOLOGICAL OUTCOME WAS EVALUATED USING MEASUREMENT OF THE CERVICAL AND SEGMENTAL LORDOSIS. THE 24 PATIENTS IN THE ANTERIOR GROUP WERE TREATED USING A CORPECTOMY FOLLOWED BY PLACEMENT OF AN EXPANDABLE TITANIUM CAGE TO RECONSTRUCT THE ANTERIOR COLUMN (ADD, ULRICH GMBH & CO. KG). A CERVICAL PLATE WAS ADDED IN ALL CASES (17 CASES WITH AN ABC PLATE [AESCULAP]; 7 CASES WITH AN ALPHA SEMICONSTRAINED PLATE [STRYKER]). IN THE POSTERIOR GROUP, A 2- TO 4-LEVEL LAMINECTOMY FOLLOWED BY POSTERIOR INSTRUMENTATION WITH LATERAL MASS SCREWS WAS PERFORMED IN 10 CASES WITH THE SPINE SYSTEM EVOLUTION CERVICAL SYSTEM (AESCULAP), IN 13 CASES WITH THE S4 CERVICAL SYSTEM (B BRAUN MELSUNGEN AG), AND IN 1 CASE WITH THE OASYS SYSTEM (STRYKER). IN THE ANTERIOR GROUP, IN WHICH SEMICONSTRAINED PLATES WERE USED, FOLLOW-UP IMAGING REVEALED 1 SCREW BREAK AND 1 SCREW LOOSENING WITHOUT THE NECESSITY OF A REVISION OPERATION.

    Description of Event or Problem · 0

    THE ARTICLE 'COMPARISON BETWEEN ANTERIOR AND POSTERIOR DECOMPRESSION WITH INSTRUMENTATION FOR CERVICAL SPONDYLOTIC MYELOPATHY: SAGITTAL ALIGNMENT AND CLINICAL OUTCOME' IN NEUROSURGERY FOCUS, VOLUME 28, MARCH 2010 WAS REVIEWED. THE AIM OF THE PRESENT STUDY WAS TO COMPARE THE EFFICACY OF MULTI-LEVEL ANTERIOR OR POSTERIOR DECOMPRESSIVE SURGERY OF THE CERVICAL SPINE WITH INSTRUMENTATION, FOCUSING ESPECIALLY ON SAGITTAL ALIGNMENT. 48 PATIENTS WERE INCLUDED IN THE STUDY: 24 IN THE ANTERIOR GROUP, AND 24 IN THE POSTERIOR GROUP. THESE PATIENTS SUFFERED FROM DEGENERATIVE CERVICAL SPINAL CANAL STENOSIS, AND UNDERWENT DECOMPRESSIVE SURGERY OF THE CERVICAL SPINE SOMETIME BETWEEN 1998 AND 2008. THE PRIMARY SYMPTOM IN ALL PATIENTS WAS MYELOPATHY (CSM). IN TOTAL, THERE WERE 29 MEN (12 ANTERIOR GROUP, 17 POSTERIOR GROUP) AND 19 WOMEN (12 ANTERIOR GROUP, 7 POSTERIOR GROUP) WHO UNDERWENT OPERATIONS. THE PATIENTS¿ AGES AT OPERATION RANGED FROM 45 TO 84 YEARS OLD, WITH A MEAN OF 64 YEARS. THE POSTERIOR GROUP (66.2 ± 8.8 YEARS) WAS SIGNIFICANTLY OLDER THAN THE ANTERIOR GROUP (60.4 ± 9.9 YEARS; P = 0.045). IN THE ANTERIOR GROUP, A 1¿2-LEVEL CORPECTOMY WAS FOLLOWED BY PLACEMENT OF A NON-STRYKER EXPANDABLE TITANIUM CAGE. IN THE POSTERIOR GROUP, A MULTILEVEL LAMINECTOMY AND POSTERIOR INSTRUMENTATION USING LATERAL MASS SCREWS WAS PERFORMED. POSTOPERATIVE RADIOGRAPHY AND CLINICAL EXAMINATIONS WERE PERFORMED AFTER 1 WEEK, 12 MONTHS, AND AT LAST FOLLOW-UP (RANGE 15¿112 MONTHS, MEAN 33 MONTHS). THE RADIOLOGICAL OUTCOME WAS EVALUATED USING MEASUREMENT OF THE CERVICAL AND SEGMENTAL LORDOSIS. THE 24 PATIENTS IN THE ANTERIOR GROUP WERE TREATED USING A CORPECTOMY FOLLOWED BY PLACEMENT OF AN EXPANDABLE TITANIUM CAGE TO RECONSTRUCT THE ANTERIOR COLUMN (ADD, ULRICH GMBH & CO. KG). A CERVICAL PLATE WAS ADDED IN ALL CASES (17 CASES WITH AN ABC PLATE [AESCULAP]; 7 CASES WITH AN ALPHA SEMICONSTRAINED PLATE [STRYKER]). IN THE POSTERIOR GROUP, A 2- TO 4-LEVEL LAMINECTOMY FOLLOWED BY POSTERIOR INSTRUMENTATION WITH LATERAL MASS SCREWS WAS PERFORMED IN 10 CASES WITH THE SPINE SYSTEM EVOLUTION CERVICAL SYSTEM (AESCULAP), IN 13 CASES WITH THE S4 CERVICAL SYSTEM (B BRAUN MELSUNGEN AG), AND IN 1 CASE WITH THE OASYS SYSTEM (STRYKER). IN THE ANTERIOR GROUP, IN WHICH SEMICONSTRAINED PLATES WERE USED, FOLLOW-UP IMAGING REVEALED 1 SCREW BREAK AND 1 SCREW LOOSENING WITHOUT THE NECESSITY OF A REVISION OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1169350 UNKNOWN_SPINE_PRODUCT POSTERIOR CERVICAL SCREW SYSTEM NKG STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown