BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - MONO/POLYAXIAL SCREWS: USS

    MDR report key: 10338752 · Received July 29, 2020

    Report

    Report Number
    8030965-2020-05389
    Event Type
    Injury
    Date Received
    July 29, 2020
    Date of Event
    January 1, 2020
    Report Date
    June 30, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NKB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. 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

    THIS REPORT IS FOR AN UNKNOWN USS MONO/POLYAXIAL SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED ON (B)(6) 2020 A TLIF (TRANSFORAMINAL LUMBAR INTERBODY FUSION) IN L4-L5 WAS PERFORMED TO TREAT SPINAL CANAL STENOSIS WITHOUT SURGICAL DELAY. THE USS II POLYAXIAL SYSTEM AND PROTI T-PAL CAGE WERE APPLIED. AFTER THE SCREWS WERE INSERTED, DECOMPRESSION WAS APPLIED. THE CAGE WAS INSERTED FROM THE RIGHT. A 45MM ROD WAS INSERTED ON THE RIGHT, A SLEEVE AND A NUT WERE DEPLOYED, AND COMPRESSION AND FINAL FIXATION WERE APPLIED. THE 40MM ROD WAS INSERTED ON THE LEFT, A SLEEVE AND A NUT WERE DEPLOYED, AND COMPRESSION AND FINAL FIXATION WERE APPLIED. A TRANSVERSE CONNECTOR WAS NOT DEPLOYED. ON (B)(6) 2020 POST OPERATIVE X-RAYS SHOWED THAT THE ROD ON THE LEFT HAD COME OFF THE L5 SCREW. ALSO, THE ROD HAD ROTATED INWARD TOGETHER WITH THE L4 SCREW. THE PATIENT HAD FELT SOME DISCOMFORT SINCE HE UNDERWENT THE INITIAL PROCEDURE. A REVISION WILL BE SCHEDULED. CONCOMITANT DEVICES REPORTED: USS-II-POLYAXIAL PEDICSCR Ø7 L45 TAN GRE (PART # 04.607.055S, LOT # 9130077, QUANTITY 1), ROD Ø6 SOFT CURV L40 TI (PART # 04.620.140S, LOT # 7630191, QUANTITY 1), USS-II POLYAXIAL 3D-HEAD F/R Ø6 TAN GREE (PART # 04.607.402S, LOT # 27P0344, QUANTITY 1), USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN (PART # 04.607.412S, LOT # 6L21284, QUANTITY 1), USS-II NUT TAN GREEN (PART # 499.294S, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) UNKNOWN USS MONO/POLYAXIAL SCREW. THIS IS REPORT 6 OF 6 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803272 UNK - MONO/POLYAXIAL SCREWS: USS ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD NKB OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention ROD Ø6 SOFT CURV L40 TI| USS-II NUT TAN GREEN| USS-II POLYAXIAL 3D-HEAD F/R Ø6 TAN GREE| USS-II POLYAXIAL SLEEVE F/R Ø6 TAN GREEN| USS-II-POLYAXIAL PEDICSCR Ø7 L45 TAN GRE