BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 19294162 · Received May 10, 2024

    Report

    Report Number
    0009617544-2024-00088
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    February 16, 2009
    Report Date
    September 27, 2024
    Manufacturer
    STRYKER SPINE-US
    Product Code
    MAX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE LOCATION UNKNOWN.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE ARTICLE 'POSTERIOR LUMBAR INTERBODY FUSION USING A UNILATERAL SINGLE CAGE AND A LOCAL MORSELIZED BONE GRAFT IN THE DEGENERATIVE LUMBAR SPINE' IN CLINICS IN ORTHOPEDIC SURGERY 2009;1:214-221, WAS REVIEWED. BETWEEN JANUARY 2003 AND SEPTEMBER 2006, 53 PATIENTS (18 M, 35 F) WHO UNDERWENT PLIF WITH A UNILATERAL SINGLE CAGE FILLED WITH LOCAL MORSELIZED BONE GRAFT WERE ENROLLED IN THIS STUDY. THE AVERAGE FOLLOW-UP DURATION WAS 31.1 MONTHS. THE CLINICAL OUTCOMES WERE EVALUATED WITH USING THE VISUAL ANALOGUE SCALE (VAS) AT THE PRE-OPERATIVE PERIOD, AT 1 YEAR POST-OPERATION AND AT THE LAST FOLLOW-UP, THE OSWESTRY DISABILITY INDEX, THE PROLO SCALE AND THE KIM & KIM CRITERIA AT THE LAST FOLLOW-UP; THE RADIOLOGICAL OUTCOMES WERE EVALUATED ACCORDING TO THE CHANGE OF BONE BRIDGING, THE RADIOLUCENCY, THE INSTABILITY AND THE DISC HEIGHT. THE INDICATION FOR SURGERY WAS SPINAL STENOSIS IN 36 CASES, SPONDYLOLISTHESIS IN 12 AND HERNIATION OF AN INTERVERTEBRAL DISC COMBINED WITH LUMBAR INSTABILITY IN 5. SINGLE-LEVEL FUSION WAS PERFORMED IN 39 PATIENTS, TWO-LEVEL FUSION WAS DONE IN 9, AND THREE-LEVEL FUSION WAS DONE IN 5. PATIENTS WERE IMPLANTED WITH TITANIUM OIC CAGES OF VARIOUS SIZES (WIDTH: 11 MM, ANGULATION: 0°, 4°, 8°, HEIGHT: 9 TO 13 MM, LENGTH: 20, 25 MM). THE RADIOLOGICAL OUTCOMES WERE AS FOLLOWS: OF THE 53 CASES, SOLID UNION WAS OBSERVED IN 50 CASES AND DELAYED UNION WAS SEEN IN 3 CASES AT THE 6TH POSTOPERATIVE MONTH, AND COMPLETE UNION WAS IDENTIFIED IN 52 CASES AT THE LAST FOLLOW-UP. RADIOLUCENCY AROUND THE CAGE AND PEDICLE SCREWS WAS NOT OBSERVED IN ANY OF THE CASES AT THE LAST FOLLOW-UP. ONE PATIENT EXPERIENCED A CAGE FRACTURE, NOTED AT THEIR FIVE-MONTH POST-OPERATIVE VISIT. THE DISC SPACE WAS MAINTAINED AND THERE WAS RADIOGRAPHIC EVIDENCE OF PROBABLE BONE BRIDGING WITHOUT RADIOLUCENCY AND WITH STABILITY ON THE FLEXION AND EXTENSION VIEWS. STABILITY WITHOUT FURTHER BREAKAGE WAS ACHIEVED AT THE 8TH POSTOPERATIVE MONTH.

    Description of Event or Problem · 0

    THE ARTICLE 'POSTERIOR LUMBAR INTERBODY FUSION USING A UNILATERAL SINGLE CAGE AND A LOCAL MORSELIZED BONE GRAFT IN THE DEGENERATIVE LUMBAR SPINE' IN CLINICS IN ORTHOPEDIC SURGERY 2009;1:214-221, WAS REVIEWED. BETWEEN JANUARY 2003 AND SEPTEMBER 2006, 53 PATIENTS (18 M, 35 F) WHO UNDERWENT PLIF WITH A UNILATERAL SINGLE CAGE FILLED WITH LOCAL MORSELIZED BONE GRAFT WERE ENROLLED IN THIS STUDY. THE AVERAGE FOLLOW-UP DURATION WAS 31.1 MONTHS. THE CLINICAL OUTCOMES WERE EVALUATED WITH USING THE VISUAL ANALOGUE SCALE (VAS) AT THE PRE-OPERATIVE PERIOD, AT 1 YEAR POST-OPERATION AND AT THE LAST FOLLOW-UP, THE OSWESTRY DISABILITY INDEX, THE PROLO SCALE AND THE KIM & KIM CRITERIA AT THE LAST FOLLOW-UP; THE RADIOLOGICAL OUTCOMES WERE EVALUATED ACCORDING TO THE CHANGE OF BONE BRIDGING, THE RADIOLUCENCY, THE INSTABILITY AND THE DISC HEIGHT. THE INDICATION FOR SURGERY WAS SPINAL STENOSIS IN 36 CASES, SPONDYLOLISTHESIS IN 12 AND HERNIATION OF AN INTERVERTEBRAL DISC COMBINED WITH LUMBAR INSTABILITY IN 5. SINGLE-LEVEL FUSION WAS PERFORMED IN 39 PATIENTS, TWO-LEVEL FUSION WAS DONE IN 9, AND THREE-LEVEL FUSION WAS DONE IN 5. PATIENTS WERE IMPLANTED WITH TITANIUM OIC CAGES OF VARIOUS SIZES (WIDTH: 11 MM, ANGULATION: 0°, 4°, 8°, HEIGHT: 9 TO 13 MM, LENGTH: 20, 25 MM). THE RADIOLOGICAL OUTCOMES WERE AS FOLLOWS: OF THE 53 CASES, SOLID UNION WAS OBSERVED IN 50 CASES AND DELAYED UNION WAS SEEN IN 3 CASES AT THE 6TH POSTOPERATIVE MONTH, AND COMPLETE UNION WAS IDENTIFIED IN 52 CASES AT THE LAST FOLLOW-UP. RADIOLUCENCY AROUND THE CAGE AND PEDICLE SCREWS WAS NOT OBSERVED IN ANY OF THE CASES AT THE LAST FOLLOW-UP. ONE PATIENT EXPERIENCED A CAGE FRACTURE, NOTED AT THEIR FIVE-MONTH POST-OPERATIVE VISIT. THE DISC SPACE WAS MAINTAINED AND THERE WAS RADIOGRAPHIC EVIDENCE OF PROBABLE BONE BRIDGING WITHOUT RADIOLUCENCY AND WITH STABILITY ON THE FLEXION AND EXTENSION VIEWS. STABILITY WITHOUT FURTHER BREAKAGE WAS ACHIEVED AT THE 8TH POSTOPERATIVE MONTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2530592 UNKNOWN_SPINE_PRODUCT INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR MAX STRYKER SPINE-US UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female