BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

    MDR report key: 8541983 · Received April 23, 2019

    Report

    Report Number
    8030965-2019-63104
    Event Type
    Injury
    Date Received
    April 23, 2019
    Date of Event
    May 24, 2011
    Report Date
    March 28, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    NKG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. DATE OF IMPLANTATION IS AN UNKNOWN DATE BETWEEN JUNE 2003 AND JULY 2007. PATIENT CODES: CODE 3191 IS NOT APPLICABLE TO THIS REPORT. 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 - MONO/POLYAXIAL SCREWS: /UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). THE REPORTED EVENT REQUIRED MEDICAL/SURGICAL INTERVENTION TO PRECLUDE PERMANENT DAMAGE TO A BODY STRUCTURE. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. INVESTIGATION SUMMARY 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, 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. (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN CHINA AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: YAN, D. ET AL (2012), ANTERIOR VERSUS POSTERIOR SURGICAL TREATMENT OF UNSTABLE THORACOLUMBAR BURST FRACTURE, EUROPEAN JOURNAL OF ORTHOPAEDIC SURGERY & TRAUMATOLOGY, VOL. 22, ISSUE 2, PAGES 103-109 (CHINA). THE AIM OF THIS RETROSPECTIVE STUDY IS TO COMPARE CLINICAL OUTCOMES OF ANTERIOR VERSUS POSTERIOR SURGERY FOR TREATMENT OF UNSTABLE THORACOLUMBAR FRACTURE. BETWEEN JUNE 2003 TO JULY 2007, A TOTAL OF 96 PATIENTS (56 MALE AND 40 FEMALE) WERE INCLUDED IN THE STUDY. 51 PATIENTS HAD ANTERIOR SURGERY BY USING TITANIUM MESH CAGE PACKED WITH LOCAL AUTOGRAFT, AND THE ANTARES OR Z-PLATE II SYSTEM (MEDTRONIC, SOFAMOR DANEK). THE REMAINING 45 PATIENTS UNDERWENT POSTERIOR PARTIAL DECOMPRESSION, AND SHORT-SEGMENT POSTERIOR INSTRUMENTATION WITH PEDICLE SCREWS WAS APPLIED BILATERALLY TO THE FIRST VERTEBRA ABOVE AND BELOW THE FRACTURE, AND LATERAL TRANSVERSE PROCESS FUSION WAS PERFORMED WITH AUTOLOGOUS ILIAC CREST BONE GRAFT. TWO INSTRUMENTATION SYSTEM OF UNIVERSAL SPINE SYSTEM (25 CASES), IN COMPARISON OF COTREL-DUBOUSSET (20 CASES) WERE USED. FOLLOW-UP OBSERVATION COULD OCCUR AT 4 AND 8 WEEKS, 3 AND 6 MONTHS, AND 1-AND 2-YEARS POST-SURGERY. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: AT LONG-TERM FOLLOW-UP, LOSS OF SAGITTAL CORRECTION IN POSTERIOR GROUP WAS MORE SEVERE THAN IN ANTERIOR GROUP (7.29 ± 2.35° VERSUS 1.68 ± 0.23°, P<0.001). THERE WAS ONE URINARY TRACT INFECTION IN ANTERIOR GROUP AND ONE SUPERFICIAL WOUND INFECTION IN POSTERIOR GROUP, WHICH RESOLVED WITH ANTIBIOTIC TREATMENT. 1 PATIENT (MALE) IDENTIFIED WITH PSEUDARTHROSIS POSTOPERATIVELY HAD SCREW BREAKAGE WITH BACK PAIN SYMPTOMS. 1 PATIENT (FEMALE) IDENTIFIED WITH PSEUDARTHROSIS POSTOPERATIVELY HAD A SCREW LOOSENING AND HAD BACK PAIN SYMPTOMS. THIS REPORT IS FOR AN UNKNOWN PEDICLE SCREWS ¿ UNIVERSAL SPINE SYSTEM. THIS IMPACTED PRODUCT CAPTURES THE ADVERSE EVENT SUCH AS SCREW BREAKAGE ON 1 PATIENT WHO HAD BACK PAIN SYMPTOM. THIS REPORT IS FOR ONE (1) UNK - MONO/POLYAXIAL SCREWS: USS. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335598 ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION NKG OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention