BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4092389 · Received September 16, 2014

    Report

    Report Number
    2520274-2014-13650
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 19, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. LITERATURE CITATION: JEFFREY D. COE, MD ET AL: NFLEX DYNAMIC STABILIZATION SYSTEM: TWO-YEAR CLINICAL OUTCOMES OF MULTI-CENTER STUDY PUBLISHED IN THE JOURNAL OF KOREAN NEUROSURGICAL SOCIETY 51: 343-349, 2012. THIS REPORT IS FOR UNKNOWN PEDICLE SCREW WITH UNKNOWN QUANTITY/UNKNOWN LOT. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    NFLEX IS NOT CURRENTLY AVAILABLE FOR THE US MARKET; HOWEVER, IT IS AVAILABLE IN THE OUS MARKET. THE NFLEX STABILIZATION SYSTEM IS INTENDED FOR USE WITH PEDICLE SCREW FIXATION IN SKELETALLY MATURE PATIENTS TO PROVIDE CONTROLLED DYNAMIC STABILIZATION OF THE LUMBOSACRAL SPINE. SIMILAR STABILIZATION SYSTEMS ARE AVAILABLE IN THE US MARKET THUS THIS COMPLAINT IS BEING REPORTED. THE NFLEX SYSTEM IS COMPATIBLE WITH PEDICLE SCREW SYSTEMS, PANGEA SYSTEM AND CLICK¿X SYSTEM. THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE BY JEFFREY D. COE, MD ET AL: NFLEX DYNAMIC STABILIZATION SYSTEM: TWO-YEAR CLINICAL OUTCOMES OF MULTI-CENTER STUDY PUBLISHED IN THE JOURNAL OF KOREAN NEUROSURGICAL SOCIETY 51: 343-349, 2012. THIS WAS A RETROSPECTIVE STUDY OF 72 CONSECUTIVE PATIENTS, FROM 5 SITES, WHO UNDERWENT NFLEX STABILIZATION, BETWEEN (B)(6) 2006 AND (B)(6) 2007, AT ONE LEVEL WITH OR WITHOUT RIGID FUSION AT A CONTINUOUS LEVEL. OF THESE 72 PATIENTS, 65 WERE AVAILABLE FOR 2-YEAR FOLLOW-UP. STUDY GROUP: 65 PATIENTS (MEN = 26, WOMEN = 39); MEAN AGE OF 54.5 YEARS RANGING FROM 19-86; MEAN FOLLOW-UP WAS 25.6 MONTHS, RANGING 23-24 MONTHS. INCLUSION CRITERIA: PATIENTS WERE INCLUDED BASED ON THE PRESENCE OF DEGENERATIVE DISC DISEASE (N = 29), DEGENERATIVE SPONDYLOLISTHESIS (N = 16), LUMBAR STENOSIS (N = 9), ADJACENT SEGMENT DEGENERATION (N = 6), AND DEGENERATIVE LUMBAR SCOLIOSIS (N = 5). PREOPERATIVE IMAGING STUDIES: X-RAYS AND IN MOST CASES, COMPUTED TOMOGRAPHY AND MAGNETIC RESONANCE IMAGING (MRI). FOLLOW-UP EVALUATIONS: 3 AND 6 WEEKS (ONE CENTER ASSESSED PATIENTS AT 4 WEEKS), 3 MONTHS, 6 MONTHS, 12 AND 24 MONTHS; SOME WERE CONDUCTED THROUGH. IN SOME CASES, FOLLOW-UP EVALUATIONS WERE CONDUCTED THROUGH PHONE INTERVIEWS. RADIOGRAPHIC ASSESSMENTS INCLUDED EVIDENCE OF INSTRUMENTATION FAILURE OR SCREW LOOSENING. IMPLANT DETAILS: SINGLE DYNAMIC LEVEL (NON-FUSION) (N = ALL); TWO SINGLE-LEVEL DYNAMIC CONSTRUCTS AT NON-CONTIGUOUS LEVELS (L3-L4 AND L5-S1 (N = 2); INSTRUMENTED RIGID FUSION PERFORMED AT CONTIGUOUS LEVELS (SO CALLED ¿HYBRID FUSION¿) (N = 40); NON-FUSION DYNAMIC STABILIZATION WITHOUT FUSION SEGMENTS (N = 25); TWO-LEVEL RIGID FUSION COMBINED WITH ONE LEVEL DYNAMIC STABILIZATION AND (N = 8)3-LEVEL RIGID FUSION PLUS ONE LEVEL DYNAMIC STABILIZATION.(N = 4). DYNAMIC STABILIZATION WAS USED AT THE CONTIGUOUS SUPERIOR LEVEL IN PATIENTS (N = 33) RECEIVING THE ¿HYBRID¿ FUSION, AND WAS PLACED AT THE INFERIOR END OF THE FUSED SEGMENT(S) IN 7 (18%) OF PATIENTS RECEIVING THE HYBRID FUSION. THE MOST COMMON PATHOLOGY WAS FOR DDD AT 1 OR 2 LEVELS. THIS ARTICLE REQUIRES 11 MEDWATCH REPORTS FOR THE NFLEX SYSTEM FOR THE FOLLOWING COMPLICATIONS: DEVICE REMOVAL RELATED TO INFECTION, ADJACENT LEVEL SURGERY, ROD FRACTURE WITH (B)(6) MALE, RE-OPERATION DUE TO ADVANCED OSTEOPOROSIS AND CAGE MIGRATION, RE-OPERATION FOR A LOOSE LOCKING CAP ON PEDICLE SCREW, SCREW LOOSENING, AND UNRELATED DEATH. NOTE THAT PEDICLE SCREWS AND LOCKING CAPS WERE USED WITH THE NFLEX SYSTEM. IT IS UNKNOWN IF PANGEA OR CLICK'X WAS USED. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR AN UNKNOWN PEDICLE SCREW. A PATIENT EXPERIENCED LOOSENING OF PEDICLE SCREW. THIS PATIENT HAD A DYNAMIC LEVEL L1-L2 BUT NO SCREWS COULD BE PLACED IN L2. THEREFORE, THE DYNAMIC SEGMENT SPANNED L1-L3 WHICH LIKELY CREATED AN UNUSUALLY LONG LEVER ARM CAUSING THE SCREW TO LOOSEN. THIS IS REPORT 6 OF 8 FOR (B)(4). THIS REPLACES THE RESCINDED MEDWATCH (B)(4) NOTED AS REPORT 6 OF 9. NOTE: A TOTAL OF 8 REPORTS, NOT 9, HAVE BEEN SUBMITTED FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572846 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1