BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PLATES: SPINE

    MDR report key: 14291015 · Received May 5, 2022

    Report

    Report Number
    8030965-2022-02957
    Event Type
    Injury
    Date Received
    May 5, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    MNH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. THIS REPORT IS FOR AN UNKNOWN SPINE PLATES/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. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    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. 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. INVESTIGATION SUMMARY: PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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.

    Description of Event or Problem · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: KLEPINOWSKI T., SAGAN L., (2022) EUROQOL-5 DIMENSIONS HEALTH-RELATED QUALITY OF LIFE QUESTIONNAIRE IN CRANIOVERTEBRAL INSTABILITY TREATED WITH POSTERIOR FIXATION WITH OR WITHOUT OCCIPITAL PLATING: A COMPARATIVE STUDY WITH MATCHED DATASETS, J CRANIOVERT JUN SPINE VOLUME 13, ISSUE 1, PAGES 72-79 (POLAND). THIS OBSERVATIONAL STUDY AIMS TO PRESENT THE FIRST STUDY OF BOTH ADULTS AND PEDIATRICS, WHICH SHALL DETECT THE BASELINE HRQOL BEFORE CRANIOCERVICAL FUSION AND AT FOLLOW-UP. BETWEEN 2006 AND 2021, 60 PATIENTS (30 MALES AND 30 FEMALES) WHO UNDERWENT POSTERIOR CRANIOCERVICAL JUNCTION FUSION AT THE TERTIARY NEUROSURGICAL CENTER DUE TO CCI WERE INCLUDED IN THE STUDY. THE MEAN AGE OF THE GROUP AT THE TIME OF OPERATION WAS 37.2 YEARS (SD = 26.5). DURING C1-C2 FIXATION VIA LATERAL MASSES OF C1 AND PEDICLES OF C2, EITHER SUMMIT® SI OCT SPINAL FIXATION SYSTEM INSTRUMENTS (DEPUY SYNTHES, USA; N = 54) OR SYNAPSE¿ OCT SYSTEM (DEPUY SYNTHES, USA; N = 6) WAS USED. OCCIPITAL PLATING WAS DONE IF GROSS ATLANTO-OCCIPITAL INSTABILITY WAS PRESENT AND FOR TYPE A BASILAR INVAGINATION OF GOEL¿S CLASSIFICATION[15] WITH SEPARATE ANALYSIS FOR EACH GROUP (WITH OCCIPITAL PLATING VERSUS WITHOUT). THE MEDIAN FOLLOW-UP FOR EQ-5D WAS 26.3 MONTHS WITH AN INTERQUARTILE RANGE (IQR) OF 10.8 TO 47.3 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: - ABNORMAL POSTOPERATIVE RADIOLOGICAL EVALUATION : (N=26) DENS TO MCRAE LINE, (N=7) DENS TO CHAMBERLAIN LINE, (N=7) DENS TO MCGREGOR LINE, DENS TO WACKENHEIM LINE (N=19) , (N=16) REVISED CONDYLE-C1 INTERVAL, (N=7) BASION-DENS INTERVAL, (N=13) BASION-AXIAL INTERVAL, (N=4) SAGITTAL DIAMETER AT C1, (N=4)SAGITTAL DIAMETER AT FM . -(N=3) NEUROLOGICAL STATUS, DETERIORATED POSTOPERATIVELY. -(N=19) MYELOPATHY DID NOT IMPROVE. -14 CORTICAL BREACH THIS REPORT IS FOR AN UNKNOWN DEPUY SYNTHES SPINE SYNAPSE¿ OCT SYSTEM. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694371 UNK - PLATES: SPINE ORTHOSIS, SPONDYLOLISTHESIS SPINAL FIXATION MNH SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention