BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NFLEX CURVED ROD 65MM-STERILE

    MDR report key: 6647628 · Received June 16, 2017

    Report

    Report Number
    3003506883-2017-10114
    Event Type
    Injury
    Date Received
    June 16, 2017
    Report Date
    May 22, 2017
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    NQP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED CONCOMITANT DEVICES REPORTED. 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.

    Additional Manufacturer Narrative · 1

    PATIENT¿S YEAR OF BIRTH REPORTED AS (B)(6). A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORDS WAS COMPLETED. THE RAW MATERIAL WAS DETERMINED TO MEET ALL DIMENSIONAL AND METALLURGIC SPECIFICATIONS. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. EXPIRATION DATE AND UDI# (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT DOB & WEIGHT NOT PROVIDED FOR REPORTING. (B)(4). THE BREAKAGE OCCURRED IN (B)(6) 2016, WHEN ALSO THE REVISION SURGERY WAS PERFORMED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE 510K PENDING CLEARANCE - SPINE. (B)(4). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PRODUCT MANUFACTURING LOCATION: (B)(4) MANUFACTURING FACILITY. PRODUCT MANUFACTURING DATE: JUNE 28, 2010. PRODUCT EXPIRY DATE: MAY 01, 2015. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED NO COMPLAINT-RELATED ANOMALIES. THE DHR SHOWS THIS LOT OF N-FLEX CURVED TITANIUM RODS WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH THREE (3) NONCONFORMANCES (NCR'S) AND ONE REWORK NOTED. ONE NCR WAS WRITTEN FOR SCRATCHES ON EIGHT (8) PARTS) WHEREBY ALL EIGHT PARTS WERE DISPOSITIONED AS SCRAP. ON THE SAME NCR, THE REMAINING PARTS IN THE ORDER WERE RELEASED WITH A "USE AS IS" DETERMINATION AND ACCOMPANYING RATIONALE BY PRODUCT DEVELOPMENT ENGINEERING FOR ETCH ORIENTATION. A SECOND NCR WAS WRITTEN FOR THE CURVED ROD FOR AN UNDERSIZED ROD RADIUS. THE RODS WERE SUCCESSFULLY REWORKED AN FULLY REINSPECTED AND FOUND TO CONFORM AND THEN RELEASED. THE THIRD NCR WAS WRITTEN ON THE MOLDED SPACER ASSEMBLY FOR A COSMETIC CONDITION OF "PART LINES" WHICH WAS ALSO RELEASED UNDER A "USE AS IS" DISPOSITION WITH RATIONALE. THIS 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 ONE REWORK WAS PERFORMED WITHOUT AN NCR FOR THE PURPOSE OF CONFIRMING THE ABSENCE OF BURRS FOLLOWED BY A FULL VERIFICATION BURR INSPECTION. 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

    CONCOMITANT DEVICES: VERTEBRAL SPACER-CR LORDOTIC 5MM HEIGHT (PART 889.921S, LOT 2665194, QUANTITY 1); VERTEBRAL SPACER-CR LORDOTIC 6MM HEIGHT (PART 889.922S, LOT 8052345, QUANTITY 1); VERTEBRAL SPACER-CR LORDOTIC 6MM HEIGHT (PART 889.922S, LOT 7889781, QUANTITY 1).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TWO NFLEX (RODS) BROKE POSTOPERATIVELY. THE BREAKAGE OCCURRED IN (B)(6) 2016, WHEN ALSO THE REVISION SURGERY WAS PERFORMED. THE INITIAL IMPLANT SURGERY TOOK PLACE ON (B)(6) 2011. COMPLAINT INVOLVES 2 PARTS. CONCOMITANT DEVICES: VERTEBRAL SPACERS 1 X 889.921S, 2 X 889.922S AND 1X LOT 238600 / UNKNOWN. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428234 NFLEX CURVED ROD 65MM-STERILE ROD N-HANCE 150MM NQP SYNTHES ELMIRA 6379171

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention LORDOTIC VERTEBRAL SPACERS 1 X 889.921S| LORDOTIC VERTEBRAL SPACERS 2 X 889.922S