BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI HARD ROD 200MM

    MDR report key: 3643493 · Received February 24, 2014

    Report

    Report Number
    2530088-2014-00042
    Event Type
    Injury
    Date Received
    February 24, 2014
    Report Date
    January 29, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    KWQ
    PMA / PMN Number
    K943725
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: RETURNED PRODUCT WAS OBSERVED TO BE BENT IN 3 LOCATIONS ALONG THE LENGTH OF THE PRODUCT, TO EXHIBIT MULTIPLE POST PRODUCTION SCRATCHES IN THE SURFACE, AS WELL AS, MULTIPLE SMALL AREAS 1-2 SQ. MM WHERE THE ANODIZED FINISH WAS NO LONGER PRESENT. SCRATCHES AND AREAS OF MISSING ANODIZED FINISH WERE OBSERVED TO BE SPORADIC ALONG THE ENTIRE LENGTH AND OUTER SURFACE OF THE PRODUCT. ORIGINAL CHAMFERED AND ANODIZED ENDS OF THE PRODUCT WERE OBSERVED TO STILL BE PRESENT ON THE RETURNED PRODUCT. ALL MEASURABLE FEATURES IDENTIFIED AS RELEVANT TO THE COMPLAINT WERE FOUND TO MEET ESTABLISHED REQUIREMENTS. UNABLE TO VALIDATE COMPLAINT FROM A MANUFACTURING STANDPOINT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THE PRODUCT DEVELOPMENT EVENT EVALUATION IDENTIFIES THAT THE 498.108 ROD IS A HARD TITANIUM ROD FOUND IN THE DUAL OPENING USS TECHNIQUE GUIDE. THE RODS HELP TO PROVIDE RIGID POSTERIOR FIXATION WHEN USED IN CONJUNCTION WITH THE PEDICLE SCREWS. AS NOTED IN THE MANUFACTURING EVALUATIONS, THE RETURNED RODS EXHIBIT BEND ZONES WHICH CORRELATE AND CONFORM TO NORMAL KYPHOSIS AS SHOWN THE PROVIDED X-RAYS. THE STANDING FILMS CLEARLY SHOW THAT THE CONSTRUCT DID NOT PROVIDE SUFFICIENT POSTERIOR RIGIDITY TO OVERCOME THE FRACTURE AT LEVEL T11. THE STANDING FILMS SHOW THAT THE LACK OF ANTERIOR SUPPORT RESULTED IN THE LOSS OF ANTERIOR DISC SPACE AND MAY HAVE LED TO THE PAIN MENTIONED IN THIS COMPLAINT. THE FLEXING MENTIONED IN THE COMPLAINT CANNOT BE ASSESSED WITH THE RODS ALONE AND IT SHOULD BE NOTED THAT THE RODS WERE NOT RECEIVED FRACTURED. THIS PATHOLOGY MAY REQUIRE ANTERIOR SUPPORT ACROSS THE FRACTURED LEVEL IN ADDITION TO THE POSTERIOR CONSTRUCT TO ENSURE STABLE SUPPORT AND A RESULTING FUSION. THE USS FRACTURE TECHNIQUE GUIDE STATES THE FOLLOWING NOTE: "ANTERIOR SUPPORT MAY BE NECESSARY IN CONDITIONS MORE SEVERE THAN GRADE II." THE SURGEON PERFORMED A REVISION SURGERY AND BRIDGED THE FRACTURED LEVEL WITH AN INTERBODY CAGE (XRL) WHICH PROVIDES THE NEEDED ANTERIOR SUPPORT TO PROMOTE FUSION WHEN USED IN CONJUNCTION WITH ADEQUATE POSTERIOR FIXATION. THERE IS NO INFORMATION REGARDING THE PATIENT'S WEIGHT OR ACTIVITY LEVEL TO DETERMINE IF THESE FACTORS CONTRIBUTED TO THE FAILED SURGERY. THIS COMPLAINT IS DEEMED INDETERMINATE FROM A DESIGN PERSPECTIVE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ACTUAL EVENT DATE NOT KNOWN. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING AND NO CONCLUSION COULD BE DRAWN. THE MANUFACTURING DOCUMENTS HAVE BEEN REVIEWED AND ONE NONCONFORMANCE WAS FOUND WHEREBY 31 OUT OF 32 LOT SAMPLES WERE UNDERSIZED FOR THE D1 (OUTSIDE DIAMETER) FEATURE TO THE SPECIFIED REQUIREMENT. AS A RESULT, THE REMAINING PIECES WERE 100 PERCENT INSPECTED AND NO ADDITIONAL FAILURES WERE FOUND. DISPOSITION WAS TO SCRAP THE 31 NON CONFORMING PARTS. IT IS UNKNOWN IF THE POSSIBLE ISSUE OF UNDERSIZE IS RELATED TO THE COMPLAINT CONDITION OF PATIENT PAIN DUE TO MOTION/FLEXING. THEREFORE, THIS COMPLAINT IS INDETERMINATE UNTIL THE PRODUCT HAS BEEN EVALUATED. A REVIEW OF THE REMAINING DHR RECORDS OF THE REPORTED FINISHED GOODS LOT INDICATE THAT THE PRODUCT LOT MET ALL ESTABLISHED CRITERIA FOR RELEASE TO WAREHOUSE. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO THE PATIENT EXPERIENCING SIGNIFICANT PAIN AND THE PATIENTS RODS APPEARED TO FLEX MORE THAN INTENDED. THE SURGEON ORIGINALLY PERFORMED A POSTERIOR SPINAL FUSION ON (B)(6) 2014 DUE TO THE PATIENT HAVING ANKYLOSING SPONDYLITIS. THE SURGEON PLACED A TI USS, UNIVERSAL SPINE SYSTEM, DUAL OPENING FROM T9-L2 AND SKIPPED THE FRACTURED T11 LEVEL. IT WAS REPORTED THAT DURING THE PAST WEEK, EXACT DATE UNKNOWN, THE PATIENT EXPERIENCED SIGNIFICANT PAIN WHEN MOBILIZING. THE SURGEON REPORTED THAT THE X-RAYS TAKEN ON AN UNKNOWN DATE, SHOW THAT THE RODS APPEAR TO FLEX AT THE T11 LEVEL MORE THAN INTENDED. THE SURGEON THEN COMPARED THE UPRIGHT FILMS WITH THE SUPINE CROSS TABLE FILMS. THE SURGEON DECIDED TO PERFORM THE REVISION SURGERY ON (B)(6) 2014 TO ADDRESS THE MOTION AND THE FLEXING IN THE FRACTURE AREA. THE SURGEON REPLACED THE EXISTING TI RODS WITH 6.0 MM TAN RODS. PATIENT WAS REVISED TO A CORPECTOMY AND A XRL CAGE. THE SURGEON SUCCESSFULLY COMPLETED THE SURGERY. IT WAS FURTHER REPORTED THAT THE SURGEON FEELS THAT THE PATIENTS T11 VERTEBRAL BODY WAS COMPROMISED AND THE SCREW WHICH WAS REPLACED, WAS REPLACED DUE TO IT PULLING OUT OF THE BONE SLIGHTLY WHEN CONNECTING THE TWO NEW RODS DURING THE REVISION SURGERY AND IS NOT A PART OF THE ORIGINAL ISSUE. THE SURGEON FELT THE PATIENTS PAIN WAS DUE TO THE MOTION AND FLEXING IN THE FRACTURE AREA. ALL THE EXISTING SCREWS WERE USED DURING THE REVISION SURGERY WITH THE EXCEPTION OF THE LEFT T12 SCREW. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114348 6.0MM TI HARD ROD 200MM KWQ SYNTHES BRANDYWINE 6926775

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention