BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8570559 · Received May 1, 2019

    Report

    Report Number
    8030965-2019-63350
    Event Type
    Injury
    Date Received
    May 1, 2019
    Report Date
    April 3, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR UNKNOWN AO UNIVERSAL SPINE SYSTEM SCHANZ SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K 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. 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 AVAILABLE, 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

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: TOYONE T ET AL (2007). TRANSPEDICULAR HYDROXYAPATITE GRAFTING WITH INDIRECT REDUCTION FOR THORACOLUMBAR BURST FRACTURES WITH NEUROLOGICAL DEFICIT: A PROSPECTIVE STUDY. INDIAN JOURNAL OF ORTHOPEDICS. VOLUME 41. ISSUE 4. PAGE 368-373. (JAPAN). THE PURPOSE OF THIS STUDY WAS TO EVALUATE THE OUTCOME OF THE MANAGEMENT OF ACUTE THORACOLUMBAR BURST FRACTURES BY TRANSPEDICULAR HYDROXYAPATITE (HA) GRAFTING FOLLOWING INDIRECT REDUCTION AND PEDICLE SCREW FIXATION. FROM 2000 THROUGH 2005, 18 PATIENTS WITH THORACOLUMBAR BURST FRACTURES AND ASSOCIATED INCOMPLETE NEUROLOGICAL DEFICIT WHO WERE OPERATIVELY TREATED WITHIN FOUR DAYS OF ADMISSION WERE INCLUDED IN THE STUDY. THERE WERE 7 WOMEN AND 11 MEN WITH A MEAN AGE OF 38 YEARS (RANGE, 14 TO 59 YEARS). ALL PATIENTS WERE IMPLANTED WITH AN UNKNOWN AO UNIVERSAL SPINE SYSTEM SCHANZ SCREWS FOLLOWED BY TRANSPEDICULAR HYDROXYAPATITE (HA) GRAFTING WITH A COMPETITOR¿S DEVICE. NEUROLOGICAL ASSESSMENT WAS MADE FOR EACH PATIENT USING A RATING SYSTEM BASED ON THAT OF THE AMERICAN SPINE INJURY ASSOCIATION (ASIA) IMPAIRMENT SCALE. RADIOGRAPHIC ASSESSMENT WAS PERFORMED USING ANTEROPOSTERIOR AND LATERAL X-RAYS AND COMPUTED TOMOGRAPHY SCAN OF THE AREA OF INJURY. THE EXTENT OF INTERVERTEBRAL DISC DEGENERATION WAS GRADED ON MIDSAGITTAL T2-WEIGHTED MAGNETIC RESONANCE IMAGES ACCORDING TO THE CRITERIA OF BORENSTEIN ET AL. AS FOLLOWS: NORMAL (SCORE 0), MILD (SCORE 1); SLIGHT DEHYDRATION OF THE DISC ON T2-WEIGHTED IMAGES, MODERATE (SCORE 2); DISC DEHYDRATION AND MILD LOSS OF DISC HEIGHT AND SEVERE (SCORE 3); TOTAL DISC DEHYDRATION WITH NEARLY COMPLETE LOSS OF DISC HEIGHT. EACH DISC LEVEL, ABOVE AND BELOW THE FRACTURED VERTEBRA, WAS GRADED. THE IMPLANTS WERE REMOVED WITHIN ONE YEAR POSTOPERATIVELY AND THE PATIENTS WERE PROSPECTIVELY FOLLOWED FOR AT LEAST 2 YEARS. COMPLICATIONS WERE REPORTED AS FOLLOWS: 5 PATIENTS REPORTED MILD PAIN AT FOLLOW-UP. 1 PATIENT REPORTED MODERATE PAIN AT FOLLOW-UP. THIS REPORT IS FOR AN UNKNOWN AO UNIVERSAL SPINE SYSTEM SCHANZ SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4). A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362392 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention