BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    MDR report key: 7969788 · Received October 16, 2018

    Report

    Report Number
    8030965-2018-57353
    Event Type
    Injury
    Date Received
    October 16, 2018
    Report Date
    September 27, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    MQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. CONTINUE: ATTACHMENT PC-000291173 KWON, PAGES: 45-50 DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    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 INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EVENT: CONTINUE: ATTACHMENT (B)(4) KWON, PAGES: 16-22. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. - ATTACHMENT: [(B)(4) KWON_16-22 2018.PDF, (B)(4) KWON_23-31 2018.PDF]

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. CONTINUE: ATTACHMENT PC-000291173 KWON, PAGES: 32-39, 40-44. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. - ATTACHMENT: [(B)(4) KWON_32-39 2018.PDF, (B)(4) KWON_40-44 2018.PDF].

    Description of Event or Problem · 0

    A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH CONTINUE ATTACHMENTS: KWON, PAGES: 45-50.

    Description of Event or Problem · 0

    CONTINUE ATTACHMENT: KWON, PAGES: 16-22, 23-31.

    Description of Event or Problem · 0

    A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. CONTINUE ATTACHMENTS: KWON, PAGES: 32-39, 40-44.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. 510K: THIS REPORT IS FOR AN UNKNOWN UNK - VERTEBRAL BODY REPLACEMENT - EXPANDABLE: SYNEX /UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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 AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KWON W-K, PARK W-B, LEE G-Y, KIM JH, PARK Y-K, MOON HJ (2018). DECOMPRESSION WITH ¿LATERAL PEDICULECTOMY¿ AND CIRCUMFERENTIAL RECONSTRUCTION FOR UNSTABLE THORACOLUMBAR BURST FRACTURES: SURGICAL TECHNIQUES AND RESULTS IN 18 PATIENTS. WORLD NEUROSURGERY. DOI: 10.1016/J.WNEU.2018.07.137 (SOUTH KOREA). THIS RETROSPECTIVE STUDY AIMS TO INTRODUCE THE TECHNIQUE AND RESULTS OF A MODIFIED RETROPLEURAL-PERITONEAL LATERAL APPROACH FOR UNSTABLE THORACOLUMBAR BURST FRACTURES, FOCUSING ON DECOMPRESSION OF THE FRACTURED FRAGMENT USING LATERAL PEDICULECTOMY AND CIRCUMFERENTIAL, SINGLE STAGE, SHORT-SEGMENT RECONSTRUCTION USING EXPANDABLE TITANIUM CAGES, LATERAL FIXATION DEVICES, AND PERCUTANEOUS PEDICLE SCREW STABILIZATION. BETWEEN JANUARY 2014 AND DECEMBER 2016, 18 PATIENTS WITH SINGLE UNSTABLE, BURST THORACOLUMBAR FRACTURE WHO UNDERWENT DECOMPRESSION AND STABILIZATION USING THESE TECHNIQUE, WERE INCLUDED IN THE STUDY. THERE WERE 11 MALES AND 7 FEMALES WITH A MEAN AGE OF 54.63+/-23.49 YEARS. SURGERY WAS PERFORMED ON T12 (9 CASES), L1 (7 CASES), AND L2 (2 CASES). PATIENTS WERE IMPLANTED WITH AN UNKNOWN SYNTHES SYNEX EXPANDABLE TITANIUM CAGE FILLED WITH LOCAL AUTOLOGOUS BONE ALONG WITH A LATERAL SCREW-ROD FIXATION SYSTEM (COMPETITOR DEVICE). RADIOLOGIC OUTCOMES INCLUDING RESTORATION ANGLES (RA), LOSS OF CORRECTED ANGLES (LA), AND DECOMPRESSION RATE (DR) WERE ASSESSED. THE DR WAS CALCULATED AS (MAXIMAL POSTOPERATIVE ANTERIOR-POSTERIOR DIAMETER OF THE BONY FRAGMENT IN THE SPINAL CANAL/MAXIMAL PREOPERATIVE ANTERIOR-POSTERIOR DIAMETER OF THE BONY FRAGMENT IN THE SPINAL CANAL) X 100. POST-OPERATIVE CLINICAL OUTCOMES WERE ASSESSED USING ODOM¿S CRITERIA AND CATEGORIZED AS EXCELLENT, GOOD, SATISFACTORY AND POOR RESULTS. THESE PATIENTS¿ CLINICAL AND RADIOLOGIC OUTCOMES WERE THEN COMPARED TO A GROUP OF 32 PATIENTS WHO UNDERWENT POSTERIOR-ONLY SURGERY DURING THE SAME PERIOD. FOLLOW-UP WAS DONE UNTIL 6 MONTHS POSTOPERATIVELY. COMPLICATIONS WERE REPORTED AS FOLLOWS: 3 PATIENTS HAD TRANSIENT WEAKNESS OF LEFT HIP ADDUCTION IMMEDIATELY AFTER THE SURGERY. ALL RECOVERED THEIR STRENGTH WITHIN 2 WEEKS POST-OP. 2 PATIENTS HAD IATROGENIC SURGERY-RELATED DURAL INJURIES THAT WERE REPAIRED INTRAOPERATIVELY. 6 PATIENTS HAD DYSESTHESIA AND/OR HYPOESTHESIA ON THE INCISION SITE AT THE LEFT FLANK AREA AT 6 MONTHS POST-OP. THIS WAS RELATED TO INTERCOSTAL NERVE INJURY. 4 PATIENTS HAD SATISFACTORY CLINICAL OUTCOME PER ODOM¿S CRITERIA. THIS REPORT IS FOR ONE (1) DEVICE- AN UNKNOWN SYNTHES SYNEX EXPANDABLE TITANIUM CAGE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810363 SPINAL VERTEBRAL BODY REPLACEMENT DEVICE MQP OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention