BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANT

    MDR report key: 12448110 · Received September 9, 2021

    Report

    Report Number
    3004774118-2021-00271
    Event Type
    Malfunction
    Date Received
    September 9, 2021
    Date of Event
    January 25, 2015
    Report Date
    December 21, 2021
    Manufacturer
    K2M, INC.
    Product Code
    OVD
    PMA / PMN Number
    K142487
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ARTICLE 'RADIOLOGICAL EVALUATION OF ANTERIOR LUMBAR FUSION USING PEEK CAGES WITH ADJACENT VERTEBRAL AUTOGRAFT IN SPINAL DEFORMITY LONG FUSION SURGERIES' IN THE EUROPEAN SPINE JOURNAL, VOLUME 24 (791-799) 2015, WAS REVIEWED. VISUAL, FUNCTIONAL, DIMENSIONAL, AND MATERIAL ANALYSIS INSPECTIONS COULD NOT BE PERFORMED AS THE DEVICE(S) WERE NOT AVAILABLE. DEVICE AND COMPLAINT HISTORY RECORDS COULD NOT BE REVIEWED AS VALID LOT NUMBERS WERE NOT PROVIDED AND COULD NOT BE OBTAINED. FROM THE AVAILABLE INFORMATION, IT IS UNKNOWN IF THE DEVICES RESPECTIVE TO THIS EVENT WERE MANUFACTURED BY STRYKER AS DEVICE INFORMATION WAS NOT AVAILABLE. THE AUTHOR OF THE ARTICLE WAS CONTACTED BUT NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED, WITHOUT ADDITIONAL INFORMATION THE EVENT AND CAUSE OF THIS EVENT COULD NOT BE ESTABLISHED.

    Description of Event or Problem · 0

    THIS RECORD CAPTURES A REVIEW OF LITERATURE ARTICLE 'RADIOLOGICAL EVALUATION OF ANTERIOR LUMBAR FUSION USING PEEK CAGES WITH ADJACENT VERTEBRAL AUTOGRAFT IN SPINAL DEFORMITY LONG FUSION SURGERIES" FROM THE EUROPEAN SPINE JOURNAL. THE AIM OF THIS STUDY WAS TO EVALUATE THE RADIOGRAPHIC CHARACTERISTICS OF POLYETHERETHERKETONE (PEEK) CAGES PACKED WITH ADJACENT VERTEBRAL AUTOGRAFT MATERIAL IN LUMBAR ANTERIOR LUMBAR INTERBODY FUSION (ALIF) IN SPINAL DEFORMITY LONG FUSION SURGERIES. FROM APRIL 2008 TO APRIL 2012, 40 PATIENTS WITH CORONAL AND/OR SAGITTAL SPINE DEFORMITIES UNDERWENT STAGED CORRECTIVE SURGERY COMBINED WITH LUMBAR ALIF USING PEEK CAGES AT THE L3¿L4, L4¿L5 OR L5¿S1 SEGMENT WITH POSTERIOR LONG (C4 LEVELS) INSTRUMENTATION. THE MEAN FOLLOW-UP TIME WAS 27.5 MONTHS (13¿49 MONTHS). PATIENTS WERE EITHER IMPLANTED WITH CHESAPEAKE CAGES OR A COMPETITOR'S CAGE. ALL PATIENTS UNDERWENT POSTERIOR FUSION TO THE SACRUM OR ILIUM USING PEDICLE SCREW SYSTEMS DURING THE SECOND STAGE OF SURGERY. THE AUTHOR NOTES THAT THERE WERE NO MAJOR COMPLICATIONS SUCH AS INFECTION, VERTEBRAL COMPRESSION FRACTURE, PSEUDARTHROSIS, OR GRAFT COLLAPSE. IT WAS REPORTED THAT AN UNKNOWN AMOUNT OF CAGES IN AN UNKNOWN AMOUNT OF PATIENTS MIGRATED SLIGHTLY POST-OPERATIVELY. IT IS UNKNOWN IF REVISION SURGERY WAS PERFORMED OR IF THESE PATIENTS WERE IMPLANTED WITH CHESAPEAKE CAGES.

    Additional Manufacturer Narrative · 1

    STATUS AND LOCATION OF THE DEVICE IS UNKNOWN.

    Description of Event or Problem · 1

    THIS RECORD CAPTURES A REVIEW OF LITERATURE ARTICLE 'RADIOLOGICAL EVALUATION OF ANTERIOR LUMBAR FUSION USING PEEK CAGES WITH ADJACENT VERTEBRAL AUTOGRAFT IN SPINAL DEFORMITY LONG FUSION SURGERIES" FROM THE EUROPEAN SPINE JOURNAL. THE AIM OF THIS STUDY WAS TO EVALUATE THE RADIOGRAPHIC CHARACTERISTICS OF POLYETHERETHERKETONE (PEEK) CAGES PACKED WITH ADJACENT VERTEBRAL AUTOGRAFT MATERIAL IN LUMBAR ANTERIOR LUMBAR INTERBODY FUSION (ALIF) IN SPINAL DEFORMITY LONG FUSION SURGERIES. FROM APRIL 2008 TO APRIL 2012, 40 PATIENTS WITH CORONAL AND/OR SAGITTAL SPINE DEFORMITIES UNDERWENT STAGED CORRECTIVE SURGERY COMBINED WITH LUMBAR ALIF USING PEEK CAGES AT THE L3¿L4, L4¿L5 OR L5¿S1 SEGMENT WITH POSTERIOR LONG (C4 LEVELS) INSTRUMENTATION. THE MEAN FOLLOW-UP TIME WAS 27.5 MONTHS (13¿49 MONTHS). PATIENTS WERE EITHER IMPLANTED WITH CHESAPEAKE CAGES OR A COMPETITOR'S CAGE. ALL PATIENTS UNDERWENT POSTERIOR FUSION TO THE SACRUM OR ILIUM USING PEDICLE SCREW SYSTEMS DURING THE SECOND STAGE OF SURGERY. THE AUTHOR NOTES THAT THERE WERE NO MAJOR COMPLICATIONS SUCH AS INFECTION, VERTEBRAL COMPRESSION FRACTURE, PSEUDARTHROSIS, OR GRAFT COLLAPSE. IT WAS REPORTED THAT AN UNKNOWN AMOUNT OF CAGES IN AN UNKNOWN AMOUNT OF PATIENTS MIGRATED SLIGHTLY POST-OPERATIVELY. IT IS UNKNOWN IF REVISION SURGERY WAS PERFORMED OR IF THESE PATIENTS WERE IMPLANTED WITH CHESAPEAKE CAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343397 UNKNOWN IMPLANT INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR OVD K2M, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown