BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4698650 · Received April 16, 2015

    Report

    Report Number
    2520274-2015-12958
    Event Type
    Injury
    Date Received
    April 16, 2015
    Report Date
    March 25, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THIS REPORT IS FOR UNKNOWN PLATES/UNKNOWN PART/UNKNOWN LOT. (B)(4) - FOR DURAL TEAR. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: LIEBERMAN, I. AND WEBB, J. (1998). OCCIPITO-CERVICAL FUSION USING POSTERIOR TITANIUM PLATES. EUR SPINE JOURNAL, 7, 308¿312. THE PURPOSE OF THIS STUDY WAS TO DETERMINE THE EFFECTIVENESS AND ADVANTAGES OF TITANIUM PLATE FIXATION WHEN USED TO STABILIZE THE OCCIPITO-CERVICAL JUNCTION. BEGINNING (B)(6) 1991 TO (B)(6) 1994, 13 PATIENTS WITH OCCIPITOCERVICAL INSTABILITY OR ATLANTO-AXIAL INSTABILITY UNDERWENT OCCIPITO-CERVICAL FUSION USING POSTERIOR TITANIUM PLATES 3.5 MM (8 AND 12 MM HOLE SPACING). THE PLATES WERE CONTOURED TO THE OCCIPITO-CERVICAL JUNCTION AND FASTENED TO THE SKULL WITH SCREWS, AND TO THE SPINE WITH LATERAL MASS SCREWS. THE PATIENTS WERE FOLLOWED PROSPECTIVELY CLINICALLY AND RADIOGRAPHICALLY TO A MINIMUM OF 24 MONTHS. OUTCOME PARAMETERS INCLUDED PERI-OPERATIVE MORBIDITY AND COMPLICATIONS, HARDWARE INTEGRITY, SPINAL ALIGNMENT, FUSION, AND NEUROLOGICAL STATUS. TWELVE OF THIRTEEN PATIENTS WENT ON TO SOLID FUSION RADIOLOGICALLY AND CLINICALLY, AND RECOVERED OR IMPROVED FROM THEIR MYELOPATHY. ONE PATIENT DID NOT. THREE PATIENTS HAD RADIOGRAPHIC EVIDENCE THAT TWO SCREWS WERE LOOSE AND ONE SCREW WAS BROKEN. THERE WERE NO INSTANCES OF PLATE BREAKAGE. A (B)(6) FEMALE, EXPERIENCED A PSEUDOARTHROSIS WITH NO PROGRESSION OF BASILAR INVAGINATION OR LOSS OF REDUCTION AT THE ATLANTO-AXIAL INTERVAL. SHE DID NOT RECOVER FROM HER MYELOPATHY. ON HER LATEST PLAIN RADIOGRAPHS THERE WAS EVIDENCE OF A LOOSE SCREW AND REPORTED NECK PAIN. THE PATIENT HAD SEVERE MULTIPLE MYELOMA AND WAS BEING TREATED WITH CHEMOTHERAPY AND RADIATION THERAPY. THE AUTHOR¿S SUSPECTED THAT THE OUTCOME WAS DUE TO A COMBINATION OF PROLONGED NEURAL COMPRESSION AND HER UNDERLYING PATHOLOGY. THE PATIENT DIED 16 MONTHS POST-OPERATIVELY. INTRA-OPERATIVELY ON THE SKULL SIDE THERE WAS ONE INSTANCE OF VENOUS SINUS PENETRATION AND THREE INSTANCES OF DURAL PENETRATION. IN THE SUB-AXIAL SPINE THERE WAS ONE INSTANCE OF VERTEBRAL ARTERY INJURY. THE VENOUS SINUS INJURY WAS FROM A HOLE DRILLED ABOVE THE NUCHAL LINE. THE HOLE WAS FILLED WITH BONE WAX, THE PLATE WAS REPOSITIONED, AND NEW ANATOMICALLY APPROPRIATE HOLES WERE DRILLED. THE VERTEBRAL ARTERY INJURY OCCURRED AT THE C5 LEVEL SECONDARY TO A MISDIRECTED DRILL HOLE. THIS WAS FILLED WITH BONE WAX AND A NEW HOLE WAS DRILLED AIMING FURTHER LATERALLY. THE DURAL TEARS WERE TREATED WITH BONE WAX FOLLOWED BY SCREW PLACEMENT. NO PATIENT DEVELOPED ANY IMMEDIATE OR LONG-TERM SEQUELAE AS A RESULT OF THESE INTRA-OPERATIVE COMPLICATIONS. THIS REPORT IS AGAINST UNKNOWN PLATES REGARDING 3 DURAL PENETRATIONS. THIS IS REPORT 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254144 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention