BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WASHER 13.0MM

    MDR report key: 2192586 · Received July 1, 2011

    Report

    Report Number
    1719045-2011-00503
    Event Type
    Injury
    Date Received
    July 1, 2011
    Date of Event
    August 7, 2007
    Report Date
    June 7, 2007
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTN
    PMA / PMN Number
    PREAMEND
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT NUMBER: INFORMATION WAS NOT PROVIDED DURING INITIAL REPORT. ADD'L INFO HAS BEEN REQUESTED. DEVICE WAS NOT EXPLANTED. MFR DATE CAN NOT BE DETERMINED WITHOUT A LOT NUMBER. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. CORRECTED INFORMATION: CHANGE FROM RM TO SI.

    Description of Event or Problem · 1

    THIS IS REPORT 3 OF 4 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PT IS PART OF A (B)(4) STUDY. STATUS POST ANTERIOR POSTERIOR L4-L5, L5-S1 SPINAL FUSION IN 2004, PT DEVELOPED PSEUDOARTHROSIS. EXPLORATION POSTERIOR FUSION OCCURRED. ON (B)(6) 2007; COMPETITOR HARDWARE WAS REMOVED AND REPLACED AT L4-S1 AND PT RECEIVED AN ILIAC CREST BONE GRAFT. SYNTHES HARDWARE REMAINED INTACT. THIS IS THE THIRD OF FOUR REPORTS FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WASHER 13.0MM WASHER HTN SYNTHES (USA) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention SCREWS| WASHER