BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

    MDR report key: 5159575 · Received October 19, 2015

    Report

    Report Number
    2520274-2015-16507
    Event Type
    Injury
    Date Received
    October 19, 2015
    Report Date
    September 28, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. GOLEMBESKI, SCOTT; LINDLEY, EMILY M.; SOPHOCLES, ARIS; MCBETH, ZACHARY L.; BURGER, EVALINA L.; PATEL, VIKAS V. (2013) ¿TRANSLATING VERSUS NONTRANSLATING CERVICAL PLATES¿ MARCH/APRIL 2013 - VOLUME 24 - ISSUE 2 - P 165¿170. THIS REPORT IS FOR AN UNKNOWN VECTRA VARIABLE ANGLE PLATES, UNKNOWN ITEM NUMBER/UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4). 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 COMPLAINT HAS BEEN INITIATED AFTER REVIEW OF THE FOLLOWING ARTICLE: GOLEMBESKI, SCOTT; LINDLEY, EMILY M.; SOPHOCLES, ARIS; MCBETH, ZACHARY L.; BURGER, EVALINA L.; PATEL, VIKAS V. (2013) TRANSLATING VERSUS NONTRANSLATING CERVICAL PLATES MARCH/APRIL 2013 - VOLUME 24 - ISSUE 2 - P 165-170. THE PURPOSE OF THIS STUDY WAS TO DETERMINE WHETHER DYNAMIC TRANSLATING CERVICAL PLATES ARE ASSOCIATED WITH IMPROVED RADIOGRAPHIC OUTCOMES AS COMPARED WITH VARIABLE-ANGLE SCREW PLATES IN PATIENTS UNDERGOING ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF). THE METHOD USED WAS A RETROSPECTIVELY REVIEWED MEDICAL RECORDS AND POSTOPERATIVE RADIOGRAPHIC FILMS (3, 6, AND 12 MONTHS) OF PATIENTS WHO UNDERWENT SINGLE AND MULTILEVEL ACDF USING EITHER DYNAMIC TRANSLATING OR VARIABLE-ANGLE PLATES. DATA WERE ANALYZED RELATIVE TO MEAN DISPLACEMENT OF VERTEBRAE, NUMBER OF VERTEBRAE FUSED, FUSION STATUS, AND COBB ANGLE. THE RESULTS OF THIS STUDY STATES OF THE 50 PATIENTS IN THIS STUDY, 24 RECEIVED TRANSLATING PLATES AND 26 RECEIVED VARIABLE-ANGLE PLATES. RADIOGRAPHIC OUTCOMES WERE SIMILAR BETWEEN THE TWO GROUPS WHEN LOOKING AT MEAN DISPLACEMENT OF VERTEBRAE, NUMBER OF VERTEBRAE FUSED, AND FUSION STATUS. WE OBSERVED A HIGHER RATE OF COBB ANGLE CHANGE GREATER THAN 3 DEGREES WITH TRANSLATING PLATES. ADDITIONALLY, WE OBSERVED A TREND TOWARD LOSS OF LORDOSIS IN THE TRANSLATING GROUP AND INCREASED LORDOSIS IN THE VARIABLE-ANGLE GROUP. THE CONCLUSION OF THIS STUDY FAILED TO CONFIRM THEIR HYPOTHESIS THAT TRANSLATING PLATES ARE ASSOCIATED WITH HIGHER FUSION RATES THAN VARIABLE-ANGLE PLATES. A HIGHER RATE OF COBB ANGLE CHANGE ALONG WITH A DECREASE IN MEAN COBB ANGLE WAS OBSERVED IN THE TRANSLATING GROUP. LOSS OF LORDOSIS IN THE TRANSLATING GROUP MAY SUGGEST A NEGATIVE IMPACT WITH THESE PLATES, INCLUDING LESS IDEAL ALIGNMENT OF THE SPINE. COMPLICATION INCLUDED: IT WAS REPORTED THAT 1 PATIENT THAT UNDERWENT SPINE FUSIONS FOR ANTERIOR CERVICAL DISCECTOMY AND FUSION (ACDF) SURGERY USING SYNTHES VECTRA VARIABLE-ANGLE PLATES, AT 12 MONTHS POST-OPERATIVELY PRESENTED WITH A NON-UNION AND LOSS OF LORDOSIS. (SI) (B)(4). THIS REPORT IS FOR AN UNKNOWN SYNTHES VECTRA VARIABLE-ANGLE PLATES, UNKNOWN PART NUMBER AND LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690505 APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention