BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    MDR report key: 11327002 · Received February 15, 2021

    Report

    Report Number
    1030489-2021-00194
    Event Type
    Malfunction
    Date Received
    February 15, 2021
    Date of Event
    April 10, 2019
    Report Date
    March 27, 2025
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    Product Code
    NKB
    PMA / PMN Number
    K170679
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    SPONSOR ASSESSMENT: POSSIBLE RELATED TO THE PROCEDURE ONLY, BY SPONSOR.

    Description of Event or Problem · 0

    SPONSOR ASSESSMENT ((B)(6)): CAUSAL RELATED TO THE PROCEDURE AND NOT RELATED TO ANY DEVICE.

    Additional Manufacturer Narrative · 1

    IT IS UNCLEAR WHICH OF THE FOLLOWING SCREWS MALFUNCTIONED. HENCE DETAILS OF ALL THE PEDICAL SCREWS USED IN THE SURGERY ARE PROVIDED BELOW. 55850046545, H5416787, QUANTITY 2, 510K: K170679, UPN (B)(4). 55850047545, H5477143, QUANTITY 1, 510K: K170679, UPN. (B)(4), 55850047545, H5466704, QUANTITY 1, 510K: K170679, UPN 00643169745278. 55850046550, H5419407, QUANTITY 2, 510K: K170679, UPN (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PATIENT DEMOGRAPHICS: GENDER: FEMALE, CLINICAL ID: (B)(6), AGE. (B)(6) WEIGHT. (B)(6), RACE. WHITE, ETHNICITY: NOT HISPANIC OR LATINO SUBSTANCE USE: CURRENTLY CONSUME ALCOHOL, TOBACCO EX-USER PRE OP DIAGNOSIS: ADYNAMIC ILEUS WITH NAUSEA AND VOMITING, INSTABILITY (UP TO AND INCLUDING GRADE 2 SPONDYLOLISTHESIS, RETROLISTHESIS OR LATERAL LISTHESIS LEVELS IMPLANTED: L2-S1 2 LEVELS DATE OF IMPLANT: (B)(6) 2019, STUDY ID: (B)(6). ASSIGNMENT CONTROL IT WAS REPORTED PER CLINICAL STUDY THAT POST-OP, THE PATIENT EXPERIENCED THE FOLLOWING ADVERSE EVENT ILEUS ONSET DATE. (B)(6) 2019, INTERVENTIONS: ACTION RESULT: ELECTROLYTES ADMINISTERED NARCOTIC USE MINIMIZED; NG TUBE PLACED WITH LOW TO INTERMITTENT SUCTION DIAGNOSTICS X-RAY WAS PERFORMED ON (B)(6) 2019, WHICH SHOWED ADYNAMIC ILEUS. AGAIN, WHEN THE X-RAY WAS PERFORMED ON (B)(6) 2019, THERE WAS NO OBSTRUCTION OR ILEUS. RELATEDNESS ACCORDING TO SITE: NOT RELATED TO SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE RELATEDNESS ACCORDING TO SPONSOR: PROBABLY RELATED TO THE SURGICAL PROCEDURE BUT NOT RELATED TO ANY OF THE IMPLANTS. SEVERITY ACCORDING TO SITE: NOT A SERIOUS ADVERSE EVENT SEVERITY ACCORDING TO SPONSOR: NON SERIOUS OUTCOME OF ADVERSE EVENT: RESOLVED ON (B)(6) 2019, UPDATE RECEIVED ON (B)(6) 2019, PREGNANCY STATUS: NO DATE OF VISIT: (B)(6) 2019, SPONSOR SERIOUSNESS ASSESSMENT: NON SERIOUS UPDATE RECEIVED ON (B)(6) 2019, PREGNANCY STATUS: NO DATE OF VISIT: (B)(6) 2019, UPDATE RECEIVED ON (B)(6) 2019, PREGNANCY STATUS: NO DATE OF VISIT: (B)(6) 2019, UPDATE RECEIVED ON (B)(6) 2020. PREGNANCY STATUS SINCE LAST 12 MONTH: NO DATE OF VISIT: (B)(6) 2020, UPDATED INFORMATION RECEIVED ON (B)(6) 2021, MEDICAL IMAGE REVIEW12 MONTHS COMMENTS: D69006805 ADJUDICATED. LOOSENING OF RT L4 PEDICAL SCREW TIP. FUSION HARDWARE LIMITS EVAL OF TRANS PROC BRIDGING. OVERLAPPING ANATOMY LIMITS EVAL OF LEFT AND RIGHT INTERBODY BRIDGING. RELEVANT PATIENT MEDICAL HISTORY, INCLUDING PRE-EXISTING CONDITIONS, PREVIOUS SURGERIES, ETC: GUILLIAN BARRE; C SECTION 1989. HYSTERECTOMY 2004. C SECTION 1989. HISTORY OF UTERINE POLYPS TREATMENT PROVIDED. NONE REPORTED PATIENT OUTCOME PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225708 CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE NKB MDT SOFAMOR DANEK PUERTO RICO MFG 55850046545 H5416787

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female