BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYNESYS FUSION UNIVERSAL SPACER 6-45

    MDR report key: 5045077 · Received September 1, 2015

    Report

    Report Number
    9613350-2015-01044
    Event Type
    Injury
    Date Received
    September 1, 2015
    Date of Event
    August 14, 2015
    Report Date
    August 17, 2015
    Manufacturer
    ZIMMER GMBH
    Product Code
    NQP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER DID NOT RECEIVE DEVICES, X-RAYS, OR OTHER SOURCE DOCUMENTS FOR REVIEW AS THE PATIENT HAS NOT BEEN REVISED. AS NO LOT NUMBERS WERE PROVIDED FOR THE DEVICES, THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED.SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON OCTOBER 26, 2015. IT WAS REPORTED THAT A (B)(6) YEARS OLD FEMALE PATIENT, WHO WAS ENROLLED IN DYNESYS 522 STUDY, WAS EXPERIENCING LOWER EXTERMITY PAIN AND FLUID COLLECTION AT THE INCISION. INCISION AND DRAINED FLUID AT LUMBAR WOUND WERE PERFORMED ON (B)(6) 2015. CULTURES OBSERVED TO BE NEGATIVE AT THE TIME OF THE REPORT. PATIENT HAD GRADE 1 SPONDYLOLISTHESIS WITH STEOSIS. IMPLANT WAS LOCATED AT L4-L5, WHERE SHE HAD DISCECTOMY, LAMINECTOMY AND DECOMPRESSION AS WELL. PATIENT REMAINED HOSPITALIZED FOR OBSERVATION. NO X-RAYS OR PICTURES WERE PROVIDED. IMPLANTATION SURGERY REPORT, DATED (B)(6) 2015: PREOPERATIVE DIAGNOSIS: LUMBAR STENOSIS WITH INSTABILITY, L4-L5. OPERATIONS: L4-L5 DECOMPRESSIVE LAMINECTOMIES WITH PARTIAL FACETECTOMIES AND EXTENSIVE FORAMINOTOMIES. INSTRUMENTED FUSION L4-L5 USING ZIMMER SPINE DYNESYS SYSTEM. BILATERAL LATERAL FUSION L4-L5USING LOCALLY HARVESTED AUTOGRAFT. NO TRUE DISK RUPTURE NOTED. NO ABNORMALITIES OBSERVED. SURGERY DATED (B)(6) 2015: PREOPERATIVE DIAGNOSIS: POSTOPERATIVE COLLECTION, STATUS POST LUMBAR DECOMPRESSION AND FUSION. INDICATIONS: MRI SCANNING SHOWED SIGNIFICANT COLLECTION IN THE SUBCUTANEOUS AND SUBFASCIAL SPACES WITH COMPRESSION OF THE THECAL SAC. OPERATION: SEROSANGUINEOUS COLLECTION OF FLUID IRRIGATED AND DECOMPRESSED. SUBFASCIAL FLUID COLLECTION IRRIGATED AND REMOVED. NO OTHER ABNORMALITIES OBSERVED. ROOT CAUSE ANALYSIS: PAIN CANNOT BE RELATED TO A SINGLE SPECIFIC FAILURE MODE. BASED ON THE GIVEN INFORMATION, A FINAL ASSESSMENT IS THEREFORE NOT POSSIBLE. SHOULD ANY ADDITIONAL INFORMATION THAT CHANGES THE ASSESSMENT BECOME AVAILABLE TO US, WE WILL RE-EVALUATE THE CASE. HOWEVER, ALL POSSIBLE CAUSES RELATED TO THE ISSUES REPORTED ARE LISTEDIN THE DFMEA OT THE REPORTED DEVICE. BASED ON THE GIVEN INFORMATION AND THE RESULTS OF THE INVESTIGATION, WE WERE NOT ABLE TO IDENTIFY A SPECIFIC ROOT CAUSE FOR THIS ISSUE. THE NEED FOR CORRECTIVE MEASURES IS NOT INDICATED AND ZIMMER (B)(4) CONSIDERS THIS CASE AS CLOSED. (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS WERE REVIEWED AND FOUND TO BE CONFORMING. A CAUSE FOR THIS SPECIFIC EVENT CANNOT BE ASCERTAINED FROM THE INFORMATION PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE AND AN INVESTIGATION RESULT BE AVAILABLE, THAT CHANGES THIS ASSESSMENT, AN AMENDED MEDICAL DEVICE REPORT WILL BE SUBMITTED. ZIMMER'S REFERENCE NUMBER OF THIS FILE IS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED A DYNESYS FUSION PEDICLE+SET SCREW 6.4X45 ON (B)(6) 2015. ON (B)(6) 2015 THE PATIENT EXPERIENCED LOWER EXTREMITY PAIN. ON (B)(6) 2015 THE PATIENT WENT TO OR, INCISION AND DRAINED FLUID AT LUMBAR WOUND WERE PERFORMED. CULTURES WERE PERFORMED AND ARE NEGATIVE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 26, 2015. THE SURGICAL REPORT (IMPLANTATION) AND THE LOT NUMBER OF SOME OF THE DEVICES WERE PROVIDED. ACCORDING WITH THE INFORMATION PROVIDED, CURRENTLY THERE IS NO REVISION PLANNED AND A FOLLOW UP VISIT IN 2-4 WEEKS WILL OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578008 DYNESYS FUSION UNIVERSAL SPACER 6-45 DYNESIS SPINAL SYSTEM NQP ZIMMER GMBH NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other