BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY

    MDR report key: 4868750 · Received June 25, 2015

    Report

    Report Number
    2520274-2015-14561
    Event Type
    Injury
    Date Received
    June 25, 2015
    Date of Event
    May 30, 2014
    Report Date
    June 10, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    KWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 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 · 1

    DEVICE USED FOR TREATMENT NOT DIAGNOSIS LITERATURE CITATION: PARASPINAL MUSCLE MORPHOMETRY IN CERVICAL SPONDYLOTIC MYELOPATHY AND ITS IMPLICATIONS IN CLINICORADIOGRAPHICAL OUTCOMES FOLLOWING CENTRAL CORPECTOMY. THAKAR S ET AL, J NEUROSURG SPINE 21: 223-230, 2014 (INDIA). THIS REPORT IS FOR UNKNOWN CERVICAL SPINE LOCKING PLATES. UNKNOWN PART AND LOT NUMBERS. (B)(6). (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT 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 JOURNAL ARTICLE: PARASPINAL MUSCLE MORPHOMETRY IN CERVICAL SPONDYLOTIC MYELOPATHY AND ITS IMPLICATIONS IN CLINICORADIOGRAPHICAL OUTCOMES FOLLOWING CENTRAL CORPECTOMY. THAKAR S ET AL, J NEUROSURG SPINE 21: 223-230, 2014 (INDIA). PURPOSE OF STUDY WAS TO ASSESS THE CROSS-SECTIONAL AREAS (CSA¿S) OF THE SUPERFICIAL, DEEP FLEXOR (DF) AND DEEP EXTENSOR (DE) PARASPINAL MUSCLES IN PATIENTS WITH CERVICAL SPONDYLOTIC MYELOPATHY (CSM) , AND TO EVALUATE THEIR CORRELATIONS WITH FUNCTIONAL STATUS AND SAGITTAL SPINAL ALIGNMENT CHANGES FOLLOWING CENTRAL CORPECTOMY WITH FUSION AND PLATING. THE STUDY POPULATION INCLUDED 61 MALES AND 6 FEMALES MEAN AGE RANGE 52 TO +/- 10.37 YEARS. THE ANTERIOR CERVICAL PLATING WAS PERFORMED WITH SELF-TAPPING SCREWS AND TITANIUM PLATES WITH ONE OF THREE SYSTEMS. TWO COMPETITOR SYSTEMS AND SYNTHES CERVICAL SPINE LOCKING PLATE. COMPLICATIONS WERE REPORTED AS FOLLOWS: EIGHT PATIENTS DEMONSTRATED PSEUDOARTHROSIS ON FOLLOW UP RADIOGRAPHY SIGNIFICANT SUBSIDENCE > 2 MM OCCURRED IN 39 PATIENTS. KYPHOTIC CHANGE IN 24 PATIENTS. SIXTEEN PATIENTS HAD SIGNIFICANT, >10 %, SEGMENTAL ANGLE CHANGE AT FOLLOW UP. THREE PATIENTS HAD TRANSIENT C-5 RADICULOPATHY. ONE DEVELOPED A RECURRENT LARYNGEAL NERVE PARESIS THAT RESOLVED IN 3 MONTHS. TWO PATIENTS EXPERIENCED INTRAOPERATIVE CSF LEAK. THIS REPORT 1 OF 1 FOR COM-(B)(4). THIS REPORT IS FOR AN UNKNOWN QUANTITY OF CERVICAL SPINE LOCKING PLATES WITH AN UNKNOWN PART AND LOT NUMBERS. UDI IS UNAVAILABLE. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR ONE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411182 APPLIANCE,FIXATION,SPINAL INTERVERTEBRAL BODY KWQ SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R