BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 8495439 · Received April 9, 2019

    Report

    Report Number
    8030965-2019-62596
    Event Type
    Injury
    Date Received
    April 9, 2019
    Report Date
    March 19, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN USS PEDICLE SCREW/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DATE OF IMPLANTATION IS AN UNKNOWN DATE BETWEEN 2007 AND 2012. 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. (B)(4). 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: PERERA, A., QURESHI, A., BRECKNELL, J.E. (2015), MONO-SEGMENT FIXATION OF THORACOLUMBAR BURST FRACTURES, BRITISH JOURNAL OF NEUROSURGERY, VOL. 29 (NO. 3), 358-361 (UNITED KINGDOM). THE AIM OF THIS RETROSPECTIVE COMPARATIVE STUDY IS TO INVESTIGATE WHAT BENEFITS CAN BE DERIVED FROM A SHORTER CONSTRUCT LENGTH IN THE PEDICLE SCREW BASED SURGICAL TREATMENT OF THORACOLUMBAR BURST FRACTURE (TLBF). BETWEEN 2007 AND 2012, A TOTAL OF 22 PATIENTS (11 MALE AND 11 FEMALE) WERE DIVIDED INTO 11 PATIENTS WHO UNDERWENT SHORT SEGMENT FIXATION (SSF) AND 11 PATIENTS WHO UNDERWENT MONO-SEGMENT FIXATION (MSF) FOR THORACOLUMBAR TRAUMA. BOTH GROUPS UNDERWENT PEDICLE SCREW FIXATION ¿ UNIVERSAL SPINAL SYSTEM (USS) FRACTURE SET FROM A POSTERIOR MIDLINE APPROACH. FOLLOW UP TIME RANGED FROM 3 TO 30 MONTHS WITH A MEAN OF 7.4 IN THE MSF GROUP, AND 3 TO 6 MONTHS IN THE SSF GROUP WITH A MEAN OF 4.2 MONTHS. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: 1 REPORT OF METAL WORK REMOVAL IN THE MSF GROUP DUE TO MALPOSITIONED SCREW IN THE LEFT PEDICLE. THIS REPORT IS FOR AN UNKNOWN UNIVERSAL SPINAL SYSTEM (USS) PEDICLE SCREW. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290758 SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention