BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NFLEX CURV 1SEGM L55 PCU/TAV-ELI

    MDR report key: 3033569 · Received April 3, 2013

    Report

    Report Number
    2520274-2013-01803
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    February 6, 2013
    Report Date
    March 7, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS THE SUBJECT DEVICE WAS EVALUATED AT RMS FOUNDATION, (B)(4). THE CHEMICAL COMPOSITION OF BOTH RODS WAS TESTED BY (B)(4). THE RODS WERE FOUND TO BE MADE OF TITANIUM ALLOY ((B)(4)). A SMALL PORTION OF EACH ROD WAS SECTIONED AND PREPARED FOR METALLOGRAPHIC EXAMINATION INTO A TRANSVERSE AND LONGITUDINAL MICRO-SECTION. THE TRANSVERSE MICRO-SECTIONS OF BOTH RODS SHOWED A HOMOGENEOUSLY SHAPED ALPHA AND BETA MICROSTRUCTURE OF A1 ((B)(4)). ALSO, THE LONGITUDINAL MICRO-SECTIONS SHOWED A TYPICAL MICROSTRUCTURE FOR THIS TYPE OF MATERIAL AND ARE FREE OF ALPHA-CASE. THE METALLOGRAPHIC EXAMINATION SHOWED THAT THE MICROSTRUCTURE OF THE RODS IS COMPLYING WITH THE INTERNATIONAL STANDARDS ISO 5832-3 AND (B)(4). HARDNESS MEASUREMENTS WERE CARRIED OUT USING A VICKERS INDENTER. THE AVERAGE HARDNESS OF ROD 1 WAS FOUND TO BE (B)(4) WHICH EQUATES TO AN APPROXIMATE TENSILE STRENGTH OF (B)(4), THE AVERAGE HARDNESS OF ROD 2 WAS FOUND TO BE (B)(4) WHICH EQUATES TO AN APPROXIMATE TENSILE STRENGTH OF (B)(4)MPA. THE REQUIREMENT OF THE TENSILE STRENGTH ACCORDING TO THE INTERNATIONAL STANDARD ISO 5832-3 IS A MINIMUM VALUE OF (B)(4). THEREFORE, THE MATERIAL OF THE RODS MEETS AND EXCEEDS THE REQUIREMENTS OF THE INTERNATIONAL STANDARDS ISO 5832-3 AND (B)(4). THE DIMENSIONS OF THE RODS (AS FAR AS MEASURABLE) WERE CHECKED USING A DIGITAL SLIDING CALIPER. THE RESULTS OF THE OUTER DIAMETER WERE FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWING AND AO/ASIF SPECIFICATIONS. THE RECEIVED NFLEX RODS ARE MADE OF TWO DIFFERENT DESIGN VERSIONS. BECAUSE OF THE INTRA-OPERATIVE SHORTENED ENDS OF THE RODS IT IS NOT POSSIBLE TO TRACE THE ARTICLE NUMBER RESPECTIVELY TO ASSIGN THE RODS TO A DESIGN VERSION. AFTER BREAKING, THE FRAGMENTS RUBBED AGAINST EACH OTHER CAUSING PARTIALLY SLIGHT DESTRUCTION OF THE FRACTURE SURFACE (SHINY SURFACE, ABRADED AREAS). WEAKLY VISIBLE LINES OF REST WERE OBSERVED AND ARE AN INDICATION OF A FATIGUE FRACTURE. WHEN EXAMINING THE CAUDAL FRACTURE SURFACES USING THE SCANNING ELECTRON MICROSCOPE (SEM), THE INITIAL FRACTURE AREAS AND THE FRACTURE BEHAVIOR WERE IDENTIFIED. ON BOTH RODS THE CRACK INITIATED ON THE SURFACE OF THE ROD AND RAN THROUGH THE MATERIAL. A PATTERN OF RIPPLES OR FATIGUE STRIATIONS WAS OBSERVED AT THE CRACK PROPAGATION ZONES. EACH STRIATION REPRESENTS THE SUCCESSIVE POSITION OF AN ADVANCING CRACK FRONT. THE PRESENCE OF THESE STRIATIONS IS A CLEAR INDICATION OF A FATIGUE PROCESS. THE FRACTURE SURFACE OF ROD 1 SHOWED A PRIMARY AND A SECONDARY CRACK INITIATION ZONE INDICATING TWO-SIDED BENDING LOADS. A FATIGUE CRACK AT THE SECONDARY CRACK INITIATION ZONE IS DOCUMENTED. THE PORTION OF FORCED FRACTURE WITH DIMPLES OF APPROXIMATELY 75% IS VERY HIGH AND INDICATES HIGH DYNAMIC LOADS. THE FRACTURE SURFACE OF ROD B ALSO SHOWED FATIGUE CRACKS AT THE CRACK INITIATION ZONE. THE PORTION OF FORCED FRACTURE WITH DIMPLES WITH APPROXIMATELY 85% IS ALSO VERY HIGH. SEM OBSERVATIONS AND FINDINGS INDICATE THAT THE ROD FAILURES WERE CAUSED BY FATIGUE AND OVERLOAD. THE FAILURE OF THE INVESTIGATED NFLEX RODS WAS DUE TO DYNAMIC BENDING WHICH LED TO THE MATERIAL FATIGUE. BASED ON THE TOPOGRAPHY OF THE FRACTURE SURFACES WE CAN CONCLUDE THAT THE INVESTIGATED IMPLANT HAD TO ABSORB AND NEUTRALIZE FORCES THAT HAVE BEEN MUCH GREATER THAN THE TOLERABLE LOAD. THE INCREASE OF WEIGHT OF THE PATIENT HAS PLAYED A CERTAIN ROLE TOO. A FAILURE RESULTING FROM EITHER A MATERIAL DEFECT OR THE MANUFACTURING PROCESS CAN BE EXCLUDED.

    Description of Event or Problem · 1

    A DEVICE REPORT FROM SYNTHES (B)(6) INDICATED A HOSPITAL IN (B)(6) REPORTED: PATIENT HAD A LUMBAR DISCOPATHY, L4-L5, ON (B)(6) 2010. PATIENT DEVELOPED DEGENERATIVE DISC DISEASE IN L4, L5, S1, DATE UNKNOWN. IT WAS DISCOVERED PATIENT HAD TWO BROKEN RODS, DATE UNKNOWN. PATIENT RETURNED TO OPERATING ROOM ON (B)(6) 2013 FOR REMOVAL OF THE RODS. PATIENT WAS REVISED TO TWO RIGID RODS AND NEW LOCKING CAPS OVER THE SAME SCREWS. GOOD RESULT IN THE SECOND SURGERY, GOOD EVOLUTION. THIS IS 1 OF 2 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT IS 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136940 NFLEX CURV 1SEGM L55 PCU/TAV-ELI NQP SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention