BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT,

    MDR report key: 8077150 · Received November 16, 2018

    Report

    Report Number
    1030489-2018-01495
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    October 1, 2018
    Report Date
    November 13, 2024
    Manufacturer
    MEDTRONIC SOFAMOR DANEK
    Product Code
    MAX
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: B5 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

    UPDATE RECEIVED ON 18 OCTOBER 2024: ONSET DATE: (B)(6) 2018 AND STILL ONGOING AT STUDY EXIT. THE EVENT IS ASSESSED AS POSSIBLE RELATED TO THE PLF GRAFTING MATERIAL, TO THE POSTERIOR FIXATION AND TO THE INTERBODYFUSION DEVICE BY THE SPONSOR ONLY.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: 1) PRODUCT ID: 6661036, LOT#: 0569184W, 510(K): K172199, UDI: (B)(4), PRODUCT CODE: MAX, QTY: 1. 2) PRODUCT ID: 6661136, LOT#: 0591366W, 510(K): K172199, UDI: (B)(4), PRODUCT CODE: MAX, QTY: 1. 3) PRODUCT ID: 54840006550, LOT#: H5337223, 510(K): K091974, UDI: (B)(4), PRODUCT CODE: NKB, QTY: 1. 4) PRODUCT ID: 54840006540, LOT#: H5307510, 510(K): K091974, UDI: (B)(4), PRODUCT CODE: NKB, QTY: 1. 5) PRODUCT ID: 5440030, LOT#: H5351674, 510(K): K102555, UDI: (B)(4), PRODUCT CODE: NKB, QTY: 1. ALTHOUGH IT IS UNKNOWN IF ANY OF THE DEVICES CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILING THIS MDR FOR NOTIFICATION PURPOSES. 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. 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.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: INSTABILITY (UP TO AND INCLUDING GRADE 2 SPONDYLOLITHESIS, RETROLISTHESIS OR LATERAL LISTHESIS) NO. OF LEVELS TREATED: 2 IT WAS REPORTED THAT THE PATIENT UNDERWENT A SURGERY. POST-OP, ON (B)(6) 2018, THE PATIENT EXPERIENCED INCREASED RIGHT LEG PAIN THAT RADIATED INTO THE LATERAL THIGH. INVESTIGATION NOTED THE EVENT TO BE NON-SERIOUS. THE INVESTIGATOR DETERMINED THE ADVERSE EVENT TO BE POSSIBLY RELATED TO SURGICAL PROCEDURE, INTERBODY DEVICE, MULTIAXIAL SCREWS, RODS AND SET SCREWS. THE OUTCOME OF THE ADVERSE EVENT WAS PENDING.

    Description of Event or Problem · 1

    ACCORDING TO THE SPONSOR ASSESSMENT, THE ADVERSE EVENT WAS NOTED TO BE POSSIBLY RELATED TO INTERBODY DEVICE, MULTI-AXIAL SCREWS, RODS AND SCREWS. NO RELATEDNESS WITH THE SURGICAL PROCEDURE WAS FOUND. THE PATIENT ALSO UNDERWENT AN ADDITIONAL SURGERY ON (B)(6) 2019. ANTERIOR LUMBAR INTERBODY FUSION WAS PERFORMED AT L2-L3 VIA TRANS PSOAS LEFT-SIDED APPROACH. ATTACHMENT WAS MADE TO PRIOR L3-L5 CONSTRUCT.

    Description of Event or Problem · 1

    THE OUTCOME OF THE ADVERSE EVENT WAS RESOLVED ON (B)(6) 2019. ACCORDING TO THE SPONSOR ASSESSMENT, THE ADVERSE EVENT WAS CONSIDERED AS NON-SERIOUS.

    Description of Event or Problem · 1

    RELATEDNESS OF THE ADDITIONAL SURGICAL PROCEDURE TO SURGICAL CONSTRUCT AND/OR THE STUDY PROCEDURE: NOT RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917304 INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, MAX MEDTRONIC SOFAMOR DANEK NA SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other