BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TSRH SPINAL SYSTEM

    MDR report key: 5675369 · Received May 24, 2016

    Report

    Report Number
    1030489-2016-01505
    Event Type
    Injury
    Date Received
    May 24, 2016
    Report Date
    May 9, 2016
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    KWP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8351500, QTY: 4 (510K# K072317). PRODUCT ID: 83545401, QTY: 4 (510K# K052054). ALTHOUGH IT IS UNKNOWN WHICH OF THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. (B)(4) (REVISION SURGERY). NEITHER THE DEVICE NOR FILMS OF APPLICABLE IMAGING STUDIES WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THEREFORE, WE ARE UNABLE TO DETERMINE THE DEFINITIVE CAUSE OF THE REPORTED EVENT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON : (B)(6) 2008: PATIENT PRESENTED WITH PRE-OP DIAGNOSIS OF ADJACENT SEGMENT SPONDYLOSIS WITH STENOSIS, L2-L3. FOR WHICH PATIENT UNDERWENT FOLLOWING PROCEDURES: SEGMENTAL INSTRUMENTATION REMOVAL, T12-L1 AND L1-L2; TRANSFORAMINAL LUMBAR INTERBODY FUSION, L2-L3 USING STRUCTURAL PEEK PROSTHETIC INTERBODY DEVICE, AS WELL AS LOCAL AUTOLOGOUS BONE ALLOGRAFT AND RHBMP2; REINSTRUMENTATION L1-L2; POSTEROLATERAL ARTHRODESIS L2-L3; TRANS DECOMPRESSION OF LEFT L2-L3. PER OP NOTES.."AT LEFT L2-L3 LEVEL, PRIOR TO IMPLANT PLACEMENT OF APPROXIMATELY 4 ML OF CORTICAL CANCELLOUS ALLOGRAFT WAS PACKED ANTERIORLY AS WELL AS SMALL RHBMP2 SPONGE. THE REMAINDER OF SPONGE WAS PLACED WITHIN THE CONFINES OF THE INTERBODY PROSTHETIC DEVICE AND THEN PLACED WITHOUT DURAL OR NEURAL RETRACTION INTO THE INTERBODY SPACE. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS. ON (B)(6) 2008: PATIENT PRESENTED FOR A FOLLOW UP VISIT WHERE SHE CONTINUED TO HAVE SEVER PAIN IN LOW BACK AS WELL AS LEFT QUADRICEPS AND THIGH. ON (B)(6) 2009: PATIENT PRESENTED FOR A FOLLOW UP VISIT AND COMPLAINED OF LOW BACK PAIN OFF TO THE LEFT HAND SIDE. ASSESSMENT: STABLE SATISFACTORY POSTOPERATIVE COURSE. ON (B)(6) 2009: PATIENT PRESENTED FOR A FOLLOW UP VISIT. ASSESSMENT: STATUS POST PREVIOUS L2-3 FUSION WITH INSTRUMENTATION, DOING WELL. ON (B)(6) 2009: PATIENT UNDERWENT CT OF LUMBAR SPINE WITHOUT CONTRAST. IMPRESSION: MATURE ANTERIOR OSSEOUS FUSION AT L5-S1 WITH HEALED TWIN BONE DOWELS; ANTERIOR AND POSTERIOR SPINAL FUSION AT THE L1-2 AND L2-3 LEVELS. BILATERAL PEDICLE SCREW AT L3 AND L2 ARE IN GOOD POSITION; SOLID ANTERIOR AND POSTEROLATERAL OSSEOUS FUSION AT L1-2; SPINAL CANAL AND FORAMINA ARE ADEQUATELY PATENT THROUGHOUT THE LUMBAR SPINE. ON (B)(6) 2010: PATIENT PRESENTED FOR A FOLLOW UP VISIT WHERE SHE CONTINUED TO HAVE SEVERE INSTRUMENT RELATED PAIN IN UPPER LUMBAR SPINE. ON (B)(6) 2010: PATIENT PRESENTED FOR FOLLOWUP OF HER ANEMIA AND CHEST PAIN. PATIENT ALSO CONTINUES TO HAVE PAIN IN BACK FROM HER NECK DOWN TO HER LOWER LUMBAR REGION. ON (B)(6) 2010: PATIENT PRESENTED WITH PREOP DIAGNOSIS AS: RETAINED, PAINFUL INSTRUMENTATION, L1-L2. FOR WHICH PATIENT UNDERWENT: PEDICLE SCREW REMOVAL, L1-L2; EXPLORATION OF FUSION, L1-L2. PATIENT TOLERATED THE PROCEDURE WELL WITHOUT ANY INTRAOPERATIVE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331639 TSRH SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE KWP MEDTRONIC SOFAMOR DANEK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other| R