BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD

    MDR report key: 6882737 · Received September 21, 2017

    Report

    Report Number
    2520274-2017-12312
    Event Type
    Injury
    Date Received
    September 21, 2017
    Date of Event
    February 3, 2016
    Report Date
    September 19, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN NFLEX SYSTEM (UNKNOWN QUANTITY/UNKNOWN LOT). (OTHER NUMBER) UDI: UNKNOWN PART NUMBER, UDI IS UNAVAILABLE. THE INVESTIGATION COULD NOT BE COMPLETED; 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

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: LEE, S; JAHNG, T; KIM, H; (2016) CLINICAL EXPERIENCES OF NON-FUSION DYNAMIC STABILIZATION SURGERY FOR ADJACENT SEGMENTAL PATHOLOGY AFTER LUMBAR FUSION. INT. JOURNAL OF SPINE SURGERY, VOL 9 (8), 13 PAGES. THIS IS A RETROSPECTIVE STUDY TO REVIEW AN ALTERNATIVE TO SPINAL FUSION, NON-FUSION DYNAMIC STABILIZATION SURGERY HAS BEEN DEVELOPED, SHOWING GOOD CLINICAL OUTCOMES. IN THE PRESENT STUDY, WE INTRODUCE OUR SURGICAL SERIES, WHICH INVOLVES NON-FUSION DYNAMIC STABILIZATION SURGERY FOR ADJACENT SEGMENT PATHOLOGY (ASP) AFTER LUMBAR FUSION SURGERY. TWO TYPES OF PEDICLE-BASED DYNAMIC STABILIZATION SYSTEMS WERE APPLIED: THE DYNESYS SYSTEM AND THE NFLEX SYSTEM (SYNTHES SPINE, INC.). FROM 2003 TO 2011, 15 PATIENTS WITH SYMPTOMATIC AGGRAVATION AND RADIOLOGIC CONFIRMATION OF ASP AFTER PREVIOUS LUMBAR FUSION SURGERY HAD UNDERGONE THE NON-FUSION DYNAMIC STABILIZATION. THERE WERE 13 FEMALES AND 2 MALES, THE MEAN AGE WAS 56.2 ± 6.9 YEARS (RANGE, 43-67) UPON THE PRIOR FUSION SURGERY, 62.1 ± 6.4 YEARS (RANGE, 46-70) UPON THE NON-FUSION SURGERY, AND 68.5 ± 6.8 YEARS (RANGE, 52-77) AT THE FINAL FOLLOW-UP. THE DYNESYS SYSTEM WAS USED ON ELEVEN PATIENTS WHILE THE NFLEX SYSTEM WAS USED ON FOUR PATIENTS. PAIN WAS MEASURED BY THE VISUAL ANALOG SCALE (VAS, 0-10) AND FUNCTIONAL OUTCOME WAS ASSESSED BY THE (B)(6) VERSION OF OSWESTRY DISABILITY INDEX. THREE PATIENTS HAD PERSISTENT PAIN AFTER THEIR NON-FUSION SURGERY, AND FOUR PATIENTS OF WHICH 2 USED NFLEX (26.6%) HAD A RELAPSE OF PAIN IN THE BACK AND LEGS AFTER A MEAN OF 30 MONTHS AFTER NON-FUSION SURGERY (30.0 ± 11.3 MONTHS, RANGE, 20-43). PERSISTENT PAIN AFTER THE FUSION AND NON-FUSION SURGERIES, AS WELL AS RELAPSED PAIN AFTER THE NON-FUSION SURGERY, DID NOT AFFECT THE DIFFERENCES IN BOTH THE VAS AND ODI VALUES (ALL P > 0.05). NO PATIENT UNDERWENT ADDITIONAL SURGERY FOR ASP AFTER UNDERGOING NON-FUSION DYNAMIC STABILIZATION SURGERY. A COPY OF THE LITERATURE ARTICLE WILL BE SUBMITTED WITH THE MEDWATCH. THIS REPORT IS 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN NFLEX SYSTEM AND REFERS TO THE SERIOUS INJURY OF PATIENT NUMBER 13, (B)(6) FEMALE, WHO EXPERIENCED HAD RELAPSE OF PAIN IN THE BACK AND LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663864 ROD NQP SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention