BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 5393588 · Received January 27, 2016

    Report

    Report Number
    2520274-2016-10386
    Event Type
    Injury
    Date Received
    January 27, 2016
    Date of Event
    December 3, 2014
    Report Date
    January 20, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DATE OF THIS REPORT: (B)(6) 2016. 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR UNKNOWN SCREW UNKNOWN QUANTITY/UNKNOWN LOT. (B)(4) HARDWARE REMOVAL. 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 REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: "ANDREA PERERA, ANJUM QURESHI & JOHN EDWARD BRECKNELL (2015) MONOSEGMENT FIXATION OF THORACOLUMBAR BURST FRACTURES, BRITISH JOURNAL OF NEUROSURGERY, 29:3, 358-361. UNITED KINGDOM". A RETROSPECTIVE ANALYSIS WAS PERFORMED OF CLINICAL NOTES AND RADIOLOGY FOR PATIENTS WHO UNDERWENT SURGICAL FIXATION OF THORACOLUMBAR BURST FRACTURES (TLBFS) BETWEEN 2007 AND 2012 IN A SINGLE UK INSTITUTION. PATIENTS FOLLOWING SIGNIFICANT TRAUMA, WITH TLBF IDENTIFIED ON CT AND ELECTING TO PURSUE SURGICAL TREATMENT UNDERWENT EITHER MONO-SEGMENT FIXATION (MSF) OR SHORT SEGMENT FIXATION (SSF) ACCORDING TO SURGEON PREFERENCE. BOTH GROUPS UNDERWENT PEDICLE SCREW FIXATION (SYNTHES, USS FRACTURE SET) FROM A POSTERIOR MIDLINE APPROACH. ELEVEN PATIENTS UNDERWENT SSF, 7 MALES AND 4 FEMALES, AND ELEVEN PATIENTS, 4 MALES AND 7 FEMALES, UNDERWENT MSF FOR THORACOLUMBAR TRAUMA. 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. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE GROUPS IN TERMS OF AGE, SEX AND MECHANISM OF INJURY. THERE WERE NO REPORTS OF POSTOPERATIVE WOUND INFECTIONS IN ANY OF THE PATIENTS AND NO DECLINE IN NEUROLOGICAL FUNCTION. THERE WAS ONE REPORT OF METAL WORK REMOVAL IN THE MSF GROUP 6 MONTHS POSTOPERATIVELY DUE TO A MALPOSITIONED SCREW IN THE LEFT PEDICLE. THIS REPORT 1 OF 1 FOR (B)(4). THIS REPORT IS FOR AN UNKNOWN SCREW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51361 SCREW,FIXATION,BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention