BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 4379125 · Received January 5, 2015

    Report

    Report Number
    2520274-2014-15620
    Event Type
    Injury
    Date Received
    January 5, 2015
    Report Date
    December 10, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. "ANTERIOR LUMBER INTERBODY SURGERY FOR SPONDYLOSIS RESULTS FROM A CLASSICALLY-TRAINED NEUROSURGEON" CHATHA, G., FOO, S., LIND, C., BUDGEON, C., AND BANNAN, P. (2014). JOURNAL OF CLINICAL NEUROSCIENCE, 21: 1543-1548. THIS REPORT IS FOR UNKNOWN TITANIUM ANTERIOR LOCKING PLATE/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(6). 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 BEIGN FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE "ANTERIOR LUMBER INTERBODY SURGERY FOR SPONDYLOSIS RESULTS FROM A CLASSICALLY-TRAINED NEUROSURGEON" CHATHA, G., FOO, S., LIND, C., BUDGEON, C., AND BANNAN, P. (2014). JOURNAL OF CLINICAL NEUROSCIENCE, 21: 1543-1548. THE ARTICLES REVIEWED USE OF ANTERIOR LUMBAR SURGERY FOR DEGENERATIVE DISC DISEASE (DDD). THE STUDY REPORTS THE OUTCOMES OF (B)(6) PATIENTS WHO UNDERWENT FUSION WITH ARTIFICIAL DISK IMPLANTS (ADI), ANTERIOR LUMBAR INTERBODY FUSION (ALIF), OR A HYBRID OF ADI AND ALIF BY A SINGLE OPERATOR NEUROSURGEON. THE ALIF USED A TITANIUM ANTERIOR LOCKING PLATE (ANTERIOR TENSION BAND PLATE, SYNTHES, INC.) CLINICAL OUTCOMES WERE ASSESSED USING THE VISUAL ANALOGUE SCALE (VAS), OSWESTRY DISABILITY INDEX (ODI), SHORT FORM 36 (SF36) AND PROSPECTIVE LOG. RADIOGRAPHIC IMAGES WERE ANALYZED. CT IMAGES WERE REVIEWED. COMPLICATIONS WERE ALSO RECORDED. THERE WERE (B)(6) INSTANCES OF FAILURE OF FUSION REPORTED. THERE WERE TEN INSTANCES OF LACERATIONS TO VEINS, NINE OF WHICH WERE ASSOCIATED WITH THE ALIF SURGERY. SEVEN INSTANCES WERE TREATED INTEROPERATIVELY AND THREE WERE DETECTED POSTOPERATIVELY AS RETROPERITONEAL HAEMATOMAS, ONE OF WHICH WAS TREATED CONSERVATIVELY AND TWO WITH SUBSEQUENT SURGERY. THERE WAS ONE INSTANCE OF NEUROPRAXIA OF THE GENITOFEMORAL NERVE. THE STUDY DID NOT SPECIFY THE SURGERY WITH WHICH THE FAILURES, LACERATIONS OR NEUROPRAXIA WERE ASSOCIATED. THIS REPORT IS 1 OF 2 FOR COM-(B)(4). THIS REPORT IS FOR AN UNKNOWN LOCKING PLATE. A COPY OF THIS JOURNAL IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR AN UNKNOWN NUMBER OF DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4587 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention