BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NFLEX CURVED ROD 70MM-STERILE

    MDR report key: 6647592 · Received June 16, 2017

    Report

    Report Number
    3003506883-2017-10113
    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 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). NUMBER 510K PENDING CLEARANCE - SPINE. (B)(4). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PRODUCT MANUFACTURING LOCATION: ELMIRA MANUFACTURING FACILITY. PRODUCT MANUFACTURE DATE: JUNE 29, 2010. PART EXPIRY DATE: JUNE 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 TWO NONCONFORMANCES (NCR) AND ONE VENDOR SUPPLIER CORRECTIVE ACTION (SCAR) NOTED. THE FIRST NCR (US1047546) WAS WRITTEN AGAINST THE ASSEMBLED ROD FOR COSMETIC APPEARANCE OF THE ROD. THE NCR WAS SUBSEQUENTLY DISPOSITIONED TO SCRAP THE AFFECTED PARTS. THE SECOND NCR (US1043699) WAS WRITTEN DUE TO A COUNT MISMATCH WHEREBY IT WAS DISCOVERED THAT THE PARTS FROM NCR 1043546 HAD NOT BEEN SCRAPPED BUT WERE MIXED INTO THE LOT. AS SUCH, A FULL SORT WAS PERFORMED WITHIN NCR 1043699 AND THE AFFECTED PARTS FROM NCR 1046546 FOUND AND SCRAPPED. DUE TO THIS FAILURE TO ACCOUNT FOR ALL PARTS AND MAINTAIN LOT INTEGRITY, A SCAR WAS ISSUED (1043697) TO THE VENDOR (PRECISION MEDICAL PRODUCTS) TO ADDRESS THE LACK OF PROPER DISPOSITIONING WITHIN THEIR QUALITY SYSTEM. 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. 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 MET ALL SPECIFICATIONS WITH NO NONCONFORMANCE OR REWORK NOTED. 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.

    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 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427811 NFLEX CURVED ROD 70MM-STERILE ROD N-HANCE 150MM NQP SYNTHES ELMIRA 6379223

    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