BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6.0MM TI CURVED SOFT ROD 70MM

    MDR report key: 3150320 · Received June 6, 2013

    Report

    Report Number
    8030965-2013-02731
    Event Type
    Injury
    Date Received
    June 6, 2013
    Report Date
    May 10, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    NKB
    PMA / PMN Number
    K082572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION, COORDINATED BY SYNTHES (B)(4), WAS PERFORMED AND THE REPORT STATES THE FOLLOWING: PARTS WERE INSPECTED AND ALL THE MEASURABLE DIMENSIONS WHERE MEASURED. THE INVESTIGATION CONCLUDED THAT THE PARTS WERE MANUFACTURED ACCORDING TO DRAWINGS AND CONFORMS TO SPECIFICATIONS. IT WAS ALSO DETERMINED THE COMPLAINT CONDITION DID NOT OCCUR, OR WAS NOT RELATED TO THE MANUFACTURING OF THE PARTS; BUT OCCURRED POST-MANUFACTURING (DURING USE).

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE RETURNED PARTS DO NOT PROVIDE ANY INDICATION FOR VERTEBRAE LOCATION FOR THE RESPECTIVE 3-D HEAD OR LOCKING CAP. THE CHU ENGINEER SUCCESSFULLY ASSEMBLED ALL LOCKING CAP, 3-D HEAD COMBINATION. THESE PARTS APPEAR TO FUNCTION AS INTENDED. THE BONE SCREW FROM S1 IS THE APPROPRIATE LENGTH FOR THE RESPECTIVE PART NUMBER. THE BONE THREADS SHOW NO DAMAGE. THE ROD DOES EXHIBIT EVIDENCE OF RELATIVE MOTION AT ALL THREE SCREW LOCATIONS BETWEEN THE 3-D HEAD-CAP ASSEMBLY AND THE ROD. THE CRANIAL AND CAUDAL END OF THE ROD CAN NOT BE DETERMINED. THE CHU REVIEWED THE COMPLAINT HISTORY ON LOOSE CAPS THAT CAUSE A REVISION SURGERY. THE HISTORY SHOWS 23 LOCKING CAPS WITH THIS HAZARD FROM (B)(4) 2011 TO (B)(4) 2013. THE OCCURRENCE RATE BASED ON SALES OF THE LOCKING CAPS IN THE SAME TIME PERIOD IS .09%. THE CHU REVIEWED THE CURRENT RISK ANALYSIS FOR THIS SYSTEM ¿ (B)(4). LINE 1860 ADDRESSES THE HAZARD AND HARM OF THIS COMPLAINT. THE DESIGN RISK ASSESSMENT WILL BE REVIEWED. DUE TO THE LACK OF INFORMATION FROM THE RETURNED IMPLANTS AND COMPLAINT DESCRIPTION, THE CHU CAN NOT DETERMINE A ROOT CAUSE FOR THIS COMPLAINT. THE PARTS SEEM TO FUNCTION AS INTENDED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    THIS IS 4 OF 4 REPORTS FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH CLICK X CONSTRUCT FOR A L4-S1 TRANSFORAMINAL LUMBAR INTERBODY FUSION (TLIF) ON (B)(6) 2013. SIX WEEKS POST OPERATIVE, THE PATIENT HAD A FOLLOW-UP VISIT. UPON X-RAY, IT WAS FOUND THE ROD HAD MIGRATED NORTH, OUT OF THE S1, 3-D SCREW HEAD. PATIENT WAS RETURNED TO THE OPERATING ROOM ON (B)(6) 2013 FOR REVISION SURGERY. IT WAS NOTED THAT THE S1 SCREW WAS SLIGHTLY LOOSE, AND THERE WAS NO ROD IN THE S1 SCREW HEAD. THE S1, 3-D SCREW HEAD WAS ALSO MOBILE. THE L5 SET SCREW IN THE LOCKING CAP, WAS ALSO LOOSE. THE SURGICAL PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. THE S1 SCREW AND ALL THREE (3) 3-D HEADS, AND ALL THREE (3) LOCKING CAPS AND THE RODS WERE REPLACED. THE PATIENTS STATUS/OUTCOME WAS REPORTED AS: MILD INCISIONAL PAIN, STABLE VITAL SIGNS, PROGRESSIVELY AMBULATED, STABLE. THIS IS 4 OF 4 REPORTS FOR THE SAME EVENT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249642 6.0MM TI CURVED SOFT ROD 70MM NKB SYNTHES GMBH 7562680

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention