BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8871978 · Received August 7, 2019

    Report

    Report Number
    8030965-2019-66989
    Event Type
    Injury
    Date Received
    August 7, 2019
    Report Date
    July 10, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN - SCREWS: SPINE-US: SPINE-US/UNKNOWN LOT NUMBER. WITHOUT THE SPECIFIC PART NUMBER, THE UDI NUMBER AND 510K 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 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 MEXICO AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: BALDWIN N., HARTMANN G., WEISER M., BENZEL E., (1995), FAILURE OF A TITANIUM ANTERIOR CERVICAL PLATE IMPLANT: MICROSTRUCTURAL ANALYSIS OF FAILURE, J. NEUROSURG VOLUME 83, PAGES 741-743 (MEXICO). THIS STUDY PRESENTS A CASE REPORT OF A FEMALE PATIENT TO REPORT AN IMPLANT FAILURE INVOLVING THE FRACTURE OF A TITANIUM PLATE IMPLANT, WHICH APPEARS TO BE RARE. A CASE OF A (B)(6) YEAR-OLD WOMAN EVALUATED FOR SIGNS AND SYMPTOMS OF CERVICAL MYELOPATHY THAT WERE UNRESPONSIVE TO CONSERVATIVE TREATMENT. ANTERIOR INSTRUMENTATION WAS PERFORMED USING THE CERVICAL SPINE LOCKING PLATE SYSTEM (SYNTHES SPINE, PAOLI, PA) AND INCLUDED A TITANIUM PLATE IMPLANT AND SIX TITANIUM MORSCHER SCREWS. POSTOPERATIVELY, THE PATIENT WAS PLACED IN A PHILADELPHIA CERVICAL COLLAR AND ADVISED TO WEAR THE DEVICE AT ALL TIMES FOR 8 WEEKS. FOLLOW-UP LATERAL CERVICAL SPINE ROENTGENOGRAMS, WHICH WERE OBTAINED 6 AND 12 WEEKS POSTOPERATIVELY, SHOWED AN APPARENT SATISFACTORY PROGRESSION OF BONE FUSION. CLINICALLY, THE PREOPERATIVE SYMPTOMS IMPROVED, BUT THE PATIENT NOTED DYSPHAGIA THAT DID NOT RESOLVE OVER THE FOLLOWING MONTHS. ROENTGENOGRAMS DEMONSTRATED A FRACTURE OF THE PLATE WITHOUT EVIDENCE OF PSEUDARTHROSIS DEVELOPMENT. A BARIUM SWALLOW, SHOWING POOLING OF CONTRAST MATERIAL AT THE VALLECULA WITH NARROWING OF THE PROXIMAL ESOPHAGUS, CORRESPONDED WITH THE LOCATION OF THE PLATE FRACTURE. THE FRACTURE OCCURRED AT ONE OF THE MIDLINE HOLES, THE NARROWEST PORTION OF THE IMPLANT, AT WHICH THE CROSS-SECTIONAL AREA OF THE PLATE IS APPROXIMATELY ONE-HALF THAT OF THE MAIN BODY OF THE IMPLANT. THE ELECTRON MICROGRAPHS SHOWED A SMALL TENSILE CRACK THAT PROBABLY OCCURRED WHEN THE IMPLANT WAS CONTOURED. THE CRACK THEN GREW DUCTILELY VIA A COMBINATION OF FATIGUE AND STRESS CORROSION ACROSS APPROXIMATELY 90% OF THE SAMPLE WIDTH, AS EVIDENCED BY ITS ROUGH INTERGRANULAR FRACTURE SURFACE. THE IMPLANT FINALLY FAILED BRITTLELY BY TRANSGRANULAR FRACTURE. THE FRACTURED PLATE WAS REMOVED. AT OPERATION, THE GRAFT APPEARED TO BE SOLIDLY FUSED TO THE ADJACENT VERTEBRAE. THE PATIENT AGAIN MADE AN UNEVENTFUL RECOVERY AND THE DYSPHAGIA RESOLVED. THIS REPORT IS FOR AN UNKNOWN SYNTHES CERVICAL SPINE LOCKING PLATE SYSTEM. THIS REPORT IS 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666178 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention