BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI SYNEX(TM) II CENTRAL BODY 45MM-71MM LENGTH

    MDR report key: 2884057 · Received December 21, 2012

    Report

    Report Number
    2520274-2012-04285
    Event Type
    Injury
    Date Received
    December 21, 2012
    Report Date
    July 22, 2010
    Manufacturer
    SYNTHES
    Product Code
    MQP
    PMA / PMN Number
    K061891
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT. THIS INDIVIDUAL ADVERSE EVENT REPORT IS BEING MADE IN ACCORDANCE WITH THE SYNTHES MDR EXEMPTION REQUEST DATED (B)(4) 2011. A REVIEW OF THE EVENTS ASSOCIATED WITH THE REQUEST WAS PERFORMED AND IT WAS DETERMINED THAT NONE OF THE EVENTS CONSTITUTES SYSTEMIC ISSUES RELATED TO PRODUCT QUALITY, CHANGES IN PRODUCT DESIGN, METHOD OF USE, OR CHANGES IN EXPECTED RISK THRESHOLDS. REVIEW OF THE DATA ALSO INDICATED NO SIGNIFICANT CHANGE IN RISK/BENEFIT OF EACH PRODUCT CATEGORY, NO EVIDENCE OF DEFICIENCIES IN THE DESIGN, LABELING, OR MANUFACTURE OF THE DEVICE. AS NO LOT NUMBER WAS PROVIDED, NO DEVICE HISTORY RECORD REVIEW CAN BE PERFORMED. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION, NO FURTHER INFORMATION IS AVAILABLE ON THIS EVENT. NO FURTHER INVESTIGATION CAN BE PERFORMED.

    Description of Event or Problem · 1

    (B)(6) COMPLAINT HANDLING UNIT REPORTED A SYNEX II BROKE INTO THE BODY. DATE OF IMPLANTATION WAS (B)(6) 2009. THE PATIENT WAS SEEN FOR A FOLLOW-UP EXAMINATION, SEE X-RAYS-CDS. THE DATE THE PATIENT COLLAPSED WAS REPORTED IN (B)(6) 2009. THE PATIENT WAS REPORTED TO HAVE PAIN POST-OPERATIVELY AND AT THE FOLLOW-UP. THE LEVEL OF IMPLANTATION WAS TH 12 AND L1. THE COLLAPSED CENTRAL BODY SIZE WAS 04.808.007.45-71 MM. THE EXPANSION HEIGHT BEFORE AND AFTER RATIO COLLAPSED WITHOUT ENDPLATES WAS 73.2 MM- 67. 4 MM, IN (B)(6) 2010 AND 60.2 MM IN (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TI SYNEX(TM) II CENTRAL BODY 45MM-71MM LENGTH TI SYNEX(TM) II CENTRAL BODY MQP SYNTHES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention