BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_SPINE_PRODUCT

    MDR report key: 12037187 · Received June 21, 2021

    Report

    Report Number
    3004024955-2021-00012
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    January 1, 2014
    Report Date
    October 29, 2021
    Manufacturer
    STRYKER SPINE-US
    Product Code
    KWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE ARTICLE 'RECONSTRUCTION WITH EXPANDABLE CAGES AFTER SINGLE- AND MULTILEVEL CORPECTOMIES FOR SPINAL METASTASES: A PROSPECTIVE CASE SERIES OF 60 PATIENTS' IN THE SPINE JOURNAL, VOLUME 14 (2085-2093) 2014, WAS REVIEWED. A PROSPECTIVE COHORT STUDY OF 60 CONSECUTIVE PATIENTS WITH SPINAL METASTASES WERE TREATED WITH EXPANDABLE CAGES WITHIN A 5-YEAR PERIOD WITH A MAXIMUM FOLLOW-UP OF 6 YEARS. STRYKER DEVICES USED IN THIS STUDY ARE VLIFT CAGES (USED IN 26 CASES) AND CLIFT (USED IN 7 CASES), CATALOG AND LOT NUMBERS WERE NOT PROVIDED. SUPPLEMENTAL FIXATION BRAND USED WITH THE VLIFT CAGES IS UNKNOWN. IN ADDITION TO STRYKER DEVICES, FIVE DIFFERENT EXPANDABLE VERTEBRAL BODY REPLACEMENT SYSTEMS WERE USED. POSTOPERATIVELY, A CONVENTIONAL X-RAY WAS MADE FOLLOWED BY A CT SCAN AFTER 3 MONTHS TO EVALUATE BONY FUSION. RADIOGRAPHIC FUSION WAS OBSERVED IN 79% OF ALL CASES. THE RATE OF FUSION WAS NOT SIGNIFICANTLY DIFFERENT AMONG THE VARIOUS TYPES OF EXPANDABLE CAGES. CAGE SUBSIDENCE WAS NOTED IN 29 OUT OF 52 PATIENTS (56%), OF WHOM 15 CASES HAD 1 TO 2 MM SUBSIDENCE. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE SUBSIDENCE RATE FOR THE VARIOUS TYPES OF EXPANDABLE CAGES. NONE OF THE CASES WITH A SUBSIDENCE OF MORE THAN 4 MM WERE SYMPTOMATIC. THIS COMPLAINT ADDRESSES ONE PATIENT WHO EXPERIENCED THE LATE COMPLICATION OF BRONCHIAL PERFORATION, WHICH OCCURRED MORE THAN 4 YEARS AFTER A THREE-LEVEL CORPECTOMY OF TH4¿TH6 THAT WAS RECONSTRUCTED WITH AN EXPANDABLE CAGE AND ANTERIOR ROD FIXATION. A TRANSTHORACIC REOPERATION WAS PERFORMED WITH RECONSTRUCTION OF THE BRONCHUS AND REMOVING OF THE ANTERIOR PLATE. THE ARTICLE INDICATES THAT BRONCHIAL PERFORATION WAS CAUSED BY AN ANTERIORLY PLACED SCREW CLOSE TO THE BRONCHUS. THIS COULD BE PREVENTED BY THE USE OF LOW-PROFILE PLATING SYSTEMS OR BY COVERAGE OF THE METAL WORK WITH FASCIAE LATAE. IT IS UNKNOW IF SCREW AND PLATE INDICATED IN THIS EVENT ARE STRYKER DEVICES. THE CAUSE OF THE EVENT IS PLACING THE SCREW TO CLOSE TO BRONCHUS.

    Description of Event or Problem · 0

    THE ARTICLE 'RECONSTRUCTION WITH EXPANDABLE CAGES AFTER SINGLE- AND MULTILEVEL CORPECTOMIES FOR SPINAL METASTASES: A PROSPECTIVE CASE SERIES OF 60 PATIENTS' IN THE SPINE JOURNAL, VOLUME 14 (2085-2093) 2014, WAS REVIEWED. BETWEEN (B)(6) 2005 AND (B)(6) 2011, A TOTAL OF 95 PATIENTS WITH SPINAL METASTASES WERE SURGICALLY TREATED AT THE MEDICAL CENTER HAAGLANDEN (THE HAGUE, THE NETHERLANDS). MEAN AGE WAS 62 (RANGE 40¿77) YEARS. MOST FREQUENT SPINAL METASTASES FROM BREAST (23%), LUNG (13%), KIDNEY (17%), MULTIPLE MYELOMA (13%), AND GASTROINTESTINAL (8%) CARCINOMAS WERE TREATED, WHICH WERE LOCALIZED IN THE CERVICAL (32%), THORACIC (43%), AND LUMBAR (25%) SPINE. SIXTY PATIENTS WERE TREATED WITH EXPANDABLE CAGES IN A 5-YEAR PERIOD WITH A MAXIMUM FOLLOW-UP OF 6 YEARS. VLIFT WAS USED FOR THE RECONSTRUCTION OF THORACIC AND LUMBAR SPINE IN 26 CASES. "CLIFT" WAS USED IN 7 CASES. 1) ONE PATIENT EXPERIENCED THE SPINAL CORD INJURY AFTER A POSTERIOR CORPECTOMY AND RECONSTRUCTION AT THE LEVEL TH12, WHICH RESULTED IN MRC GRADE 3 PARESIS OF THE RIGHT LEG. (B)(6) (REVISION 02) INDICATES THAT 'DAMAGE TO NERVES' WHICH CAUSES POSSIBLE IRREVERSIBLE DAMAGE TO THE PATIENT AND WHICH REQUIRES MEDICAL INTERVENTION IS ASSOCIATED WITH A SEVERITY OF 'CRITICAL' (S4). THIS COMPLAINT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY. THE EVENT RESULTED IN DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH OF A PATIENT, USER, OR OTHER PERSON AND WILL THEREFORE BE REPORTABLE VIA MIR. 2) ONE PATIENT EXPERIENCED WEAKNESS OF THE ILIOPSOAS MUSCLE (MRC GRADE 2) AFTER ANTERIOR CORPECTOMY AND RECONSTRUCTION AT THE LEVEL L2. (B)(6) (REVISION 02) INDICATES THAT 'DAMAGE TO SOFT TISSUE' IS ASSOCIATED WITH A SEVERITY OF 'SERIOUS' (S3). THIS COMPLAINT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY. THE EVENT RESULTED IN DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH OF A PATIENT, USER, OR OTHER PERSON AND WILL THEREFORE BE REPORTABLE VIA MIR. 3) ONE PATIENT EXPERIENCED DISLOCATION OF THE CAGE, NOTED ON THE POST-OPERATIVE CT SCAN. IMPLANTATION OF THE CAGE WAS TECHNICALLY DIFFICULT BECAUSE OF SEVERE KYPHOSIS OF THE AFFECTED SEGMENT. THE PATIENT WAS RE-OPERATED SEVERAL DAYS LATER; REPOSITIONING OF THE CAGE WAS NOT PERFORMED BECAUSE OF A STABLE POSITION OF THE CAGE. THE EVENT RESULTED IN A SERIOUS INJURY OR SERIOUS DETERIORATION IN STATE OF HEALTH OF A PATIENT, USER, OR OTHER PERSON; THIS COMPLAINT WILL BE REPORTABLE TO THE FDA AND WILL BE MIR REPORTABLE. 4) ONE PATIENT EXPERIENCED ROD FRACTURE MORE THAN THREE-YEARS AFTER IMPLANTATION. PATIENT HAD BEEN IMPLANTED WITH TWO-LEVEL CORPECTOMY OF L4 AND L5 WITH POSTERIOR STABILIZATION FROM L2 AND L3 TO S1 AND THE ILIUM. THE EVENT RESULTED IN A SERIOUS INJURY OR SERIOUS DETERIORATION IN STATE OF HEALTH OF A PATIENT, USER, OR OTHER PERSON; THIS COMPLAINT WILL BE REPORTABLE TO THE FDA AND WILL BE MIR REPORTABLE. 5) ONE PATIENT EXPERIENCED THE LATE COMPLICATION OF BRONCHIAL PERFORATION, WHICH OCCURRED MORE THAN 4 YEARS AFTER A THREE-LEVEL CORPECTOMY OF TH4¿TH6 THAT WAS RECONSTRUCTED WITH AN EXPANDABLE CAGE AND ANTERIOR ROD FIXATION. THE PERFORATION WAS ATTRIBUTED TO CHRONIC IRRITATION CAUSED BY AN ANTERIORLY PLACED SCREW CLOSE TO THE BRONCHUS. A TRANSTHORACIC REOPERATION WAS PERFORMED WITH RECONSTRUCTION OF THE BRONCHUS AND REMOVING OF THE ANTERIOR PLATE. THE EVENT RESULTED IN A SERIOUS INJURY OR SERIOUS DETERIORATION IN STATE OF HEALTH OF A PATIENT, USER, OR OTHER PERSON; THIS COMPLAINT WILL BE REPORTABLE TO THE FDA AND WILL BE MIR REPORTABLE. THIS REPORT CAPTURES THE SERIOUS INJURY EVENT OF CASE 5.

    Additional Manufacturer Narrative · 1

    LOCATION OF DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    THE ARTICLE 'RECONSTRUCTION WITH EXPANDABLE CAGES AFTER SINGLE- AND MULTILEVEL CORPECTOMIES FOR SPINAL METASTASES: A PROSPECTIVE CASE SERIES OF 60 PATIENTS' IN THE SPINE JOURNAL, VOLUME 14 (2085-2093) 2014, WAS REVIEWED. BETWEEN DECEMBER 2005 AND MAY 2011, A TOTAL OF 95 PATIENTS WITH SPINAL METASTASES WERE SURGICALLY TREATED AT THE MEDICAL CENTER HAAGLANDEN (THE HAGUE, THE NETHERLANDS). MEAN AGE WAS 62 (RANGE 40¿77) YEARS. MOST FREQUENT SPINAL METASTASES FROM BREAST (23%), LUNG (13%), KIDNEY (17%), MULTIPLE MYELOMA (13%), AND GASTROINTESTINAL (8%) CARCINOMAS WERE TREATED, WHICH WERE LOCALIZED IN THE CERVICAL (32%), THORACIC (43%), AND LUMBAR (25%) SPINE. SIXTY PATIENTS WERE TREATED WITH EXPANDABLE CAGES IN A 5-YEAR PERIOD WITH A MAXIMUM FOLLOW-UP OF 6 YEARS. VLIFT WAS USED FOR THE RECONSTRUCTION OF THORACIC AND LUMBAR SPINE IN 26 CASES. "CLIFT" WAS USED IN 7 CASES. ONE PATIENT EXPERIENCED THE SPINAL CORD INJURY AFTER A POSTERIOR CORPECTOMY AND RECONSTRUCTION AT THE LEVEL TH12, WHICH RESULTED IN MRC GRADE 3 PARESIS OF THE RIGHT LEG. DR-QA-102-A (REVISION 02) INDICATES THAT 'DAMAGE TO NERVES' WHICH CAUSES POSSIBLE IRREVERSIBLE DAMAGE TO THE PATIENT AND WHICH REQUIRES MEDICAL INTERVENTION IS ASSOCIATED WITH A SEVERITY OF 'CRITICAL' (S4). THIS COMPLAINT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY. THE EVENT RESULTED IN DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH OF A PATIENT, USER, OR OTHER PERSON AND WILL THEREFORE BE REPORTABLE VIA MIR. ONE PATIENT EXPERIENCED WEAKNESS OF THE ILIOPSOAS MUSCLE (MRC GRADE 2) AFTER ANTERIOR CORPECTOMY AND RECONSTRUCTION AT THE LEVEL L2. DR-QA-102-A (REVISION 02) INDICATES THAT 'DAMAGE TO SOFT TISSUE' IS ASSOCIATED WITH A SEVERITY OF 'SERIOUS' (S3). THIS COMPLAINT WILL BE REPORTABLE TO THE FDA AS A SERIOUS INJURY. THE EVENT RESULTED IN DEATH OR SERIOUS DETERIORATION IN STATE OF HEALTH OF A PATIENT, USER, OR OTHER PERSON AND WILL THEREFORE BE REPORTABLE VIA MIR. ONE PATIENT EXPERIENCED DISLOCATION OF THE CAGE, NOTED ON THE POST-OPERATIVE CT SCAN. IMPLANTATION OF THE CAGE WAS TECHNICALLY DIFFICULT BECAUSE OF SEVERE KYPHOSIS OF THE AFFECTED SEGMENT. THE PATIENT WAS RE-OPERATED SEVERAL DAYS LATER; REPOSITIONING OF THE CAGE WAS NOT PERFORMED BECAUSE OF A STABLE POSITION OF THE CAGE. THE EVENT RESULTED IN A SERIOUS INJURY OR SERIOUS DETERIORATION IN STATE OF HEALTH OF A PATIENT, USER, OR OTHER PERSON; THIS COMPLAINT WILL BE REPORTABLE TO THE FDA AND WILL BE MIR REPORTABLE. ONE PATIENT EXPERIENCED ROD FRACTURE MORE THAN THREE-YEARS AFTER IMPLANTATION. PATIENT HAD BEEN IMPLANTED WITH TWO-LEVEL CORPECTOMY OF L4 AND L5 WITH POSTERIOR STABILIZATION FROM L2 AND L3 TO S1 AND THE ILIUM. THE EVENT RESULTED IN A SERIOUS INJURY OR SERIOUS DETERIORATION IN STATE OF HEALTH OF A PATIENT, USER, OR OTHER PERSON; THIS COMPLAINT WILL BE REPORTABLE TO THE FDA AND WILL BE MIR REPORTABLE. ONE PATIENT EXPERIENCED THE LATE COMPLICATION OF BRONCHIAL PERFORATION, WHICH OCCURRED MORE THAN 4 YEARS AFTER A THREE-LEVEL CORPECTOMY OF TH4¿TH6 THAT WAS RECONSTRUCTED WITH AN EXPANDABLE CAGE AND ANTERIOR ROD FIXATION. THE PERFORATION WAS ATTRIBUTED TO CHRONIC IRRITATION CAUSED BY AN ANTERIORLY PLACED SCREW CLOSE TO THE BRONCHUS. A TRANSTHORACIC REOPERATION WAS PERFORMED WITH RECONSTRUCTION OF THE BRONCHUS AND REMOVING OF THE ANTERIOR PLATE. THE EVENT RESULTED IN A SERIOUS INJURY OR SERIOUS DETERIORATION IN STATE OF HEALTH OF A PATIENT, USER, OR OTHER PERSON; THIS COMPLAINT WILL BE REPORTABLE TO THE FDA AND WILL BE MIR REPORTABLE. THIS REPORT CAPTURES THE SERIOUS INJURY EVENT OF CASE 5.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934159 UNKNOWN_SPINE_PRODUCT UNKNOWN KWP STRYKER SPINE-US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention