BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NFLEX CURVED ROD 60MM-STERILE

    MDR report key: 5538437 · Received March 31, 2016

    Report

    Report Number
    3003506883-2016-10058
    Event Type
    Injury
    Date Received
    March 31, 2016
    Report Date
    March 16, 2016
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    NQP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). (B)(4). THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE 510(K) NOT YET ASSIGNED FOR MARKETING IN THE USA. CLEARANCE IS PENDING. PREDICATE DEVICE K072685. A DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE RETURNED PANGEA POLYAXIAL SCREW (PART 04.620.650 / LOT 6745258) WAS EXAMINED AND THE COMPLAINT CONDITION (BROKEN POST-OPERATIVELY) WAS ABLE TO BE CONFIRMED AS THE DISTAL 24.5MM OF THE SCREW BODY WAS FOUND TO BE BROKEN AND NOT RETURNED. THE POLYAXIAL HEAD WAS FOUND TO BE SEIZED AND THE SCREW BODY THREADS/RECESSES SHOW WEAR CONSISTENT WITH POST-MANUFACTURING DAMAGE. ADDITIONALLY, THE NFLEX ROD (PART 04.600.760S / LOT 6860576) WAS EXAMINED AND THE COMPLAINT CONDITION (BROKEN POST-OPERATIVELY) WAS ABLE TO BE CONFIRMED AS THE ROD WAS FOUND TO BE BROKEN AT THE INTERSECTION OF THE SOLID AND DYNAMIC REGIONS; ALL ROD PIECES WERE RETURNED. GALLING WAS APPARENT ON THE POLYMER SLEEVE AND WITNESS MARKS WERE NOTED ALONG THE ROD, ALL OF WHICH IS CONSISTENT WITH POST-MANUFACTURING DAMAGE. A VISUAL INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. AS NO SPECIFIC ALLEGATIONS WERE MADE AGAINST THE CONCOMITANT IMPLANTS, AND NO IDENTIFIABLE DEFECTS OR DEFICIENCIES (OUTSIDE OF THOSE CONSISTENT WITH IMPLANTATION/EXPLANTATION) WERE IDENTIFIED, NO FURTHER INVESTIGATION WILL BE COMPLETED. THE RETURNED CONCOMITANT DEVICES IN THIS COMPLAINT RECORD SHOW NO EVIDENCE OF HAVING CONTRIBUTED TO THE EVENT. THE RELEVANT DRAWINGS FOR THE RETURNED NFLEX ROD WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND PRESENT REVISION): TOP-LEVEL, MOLDED SPACER, ROD. THE DESIGN, MATERIALS, AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER WITH NO MATERIAL RECORD REPORTS OR COMPLAINT-RELATED ISSUES IDENTIFIED. ONE UNRELATED NON-CONFORMANCE (NC) WAS NOTED FOR THE PART/LOT COMBINATION RELATED TO A ROD BEING UNDER BENT. AN APPROVED REWORK WAS PERFORMED TO BRING ALL RODS INTO FULL COMPLIANCE. THE NC IS NOT RELATED TO THE COMPLAINT CONDITION AS ALL DEVICES WERE WITHIN SPECIFICATION AT THE TIME OF RELEASE. ADDITIONALLY, TWO (2) NCS WERE NOTED IN THE RAW MATERIAL REVIEW: ONE (1) FOR PACKAGING DAMAGE AND ANOTHER FOR A TYPOGRAPHICAL ERROR IN THE VENDOR CERTIFICATION. NEITHER NC IS RELATED TO THE COMPLAINT CONDITION AS THE RAW MATERIALS WERE FOUND TO HAVE MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE. A DIMENSIONAL CHECK, USING NFLEX FAI, WAS NOT POSSIBLE DUE TO THE POST-MANUFACTURING DAMAGE (BROKEN ROD) AND THE ASSEMBLED STATE OF THE IMPLANT. DESTRUCTIVE TESTING WAS NOT REQUESTED AS IT WOULD COMPROMISE COMPONENTS PRIOR TO DIMENSIONAL ANALYSIS. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. DHR REVIEW ¿ PRODUCT MANUFACTURE DATE: 01 MAR 2012. PART EXPIRY DATE: 01 JAN 2017. A REVIEW OF THE DHR REVEALED NO COMPLAINT RELATED ANOMALIES. THE ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF MANUFACTURE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTED AN EVENT IN THE (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN NFLEX CURVED ROD AND A PANGEA PEDICLE SCREW BROKE POSTOPERATIVELY. THE DATE OF BREAKAGE IS UNKNOWN. INITIAL IMPLANT SURGERY TOOK PLACE ON (B)(6) 2013 AND THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2015. THE REVISION SURGERY WAS PERFORMED EARLIER THAN PLANNED DUE TO THE REPORTED DEVICE BREAKAGES. THE DEVICES AND FRAGMENTS WERE REMOVED WITHOUT COMPLICATION AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 2 OF 2 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194765 NFLEX CURVED ROD 60MM-STERILE POSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION NQP SYNTHES ELMIRA 6860576

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 04.620.000, LOT 6982139, TI PANGEA(TM) LOCKING CAP