BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSE BONE GRAFT

    MDR report key: 10172874 · Received June 19, 2020

    Report

    Report Number
    1030489-2020-00665
    Event Type
    Injury
    Date Received
    June 19, 2020
    Date of Event
    March 17, 2020
    Report Date
    April 8, 2025
    Manufacturer
    MEDTRONIC SOFAMOR DANEK USA, INC
    Product Code
    NEK
    PMA / PMN Number
    SEE H10
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED INFORMATION ADDED IN B5 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

    ADDITIONAL REVIEW OF THE EVENT SHOWS THAT THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY OR THAT THE DEVICE IN THIS REPORT HAS MALFUNCTIONED. THEREFORE, THIS EVENT DID NOT AND DOES NOT MEET THE REPORTING REQUIREMENTS IN 21 CFR 803. 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

    UPDATED INFORMATION RECEIVED ON 08-MAR-2022: OUTCOME STATUS RESOLVED OUTCOME DATE: (B)(6) 2021. PREGNANT SINCE LAST VISIT 24 MONTHS: HAS THE SUBJECT BECOME PREGNANT SINCE LAST VISIT: NO DATE OF VISIT: (B)(6) 2022, USADE/UADE ASSESSMENT: NO. DD HAVE LED TO SADE: NOT APPLICABLE.

    Additional Manufacturer Narrative · 1

    OTHER - NEUROPATHIC PAIN D4/G5: THE FOLLOWING PRODUCTS WERE USED IN THE SURGERY: PRODUCT ID: 7510800, LOT: M111804AAA (X2), PMA: P000058, UDI: (B)(4). PRODUCT ID: 55840006545, LOT: 5563767(X3), 5567563(X3), 510K: K113174, UDI: (B)(4). PRODUCT ID: 55840007540, LOT: 5473525(X2), 510K: K113174, UDI: (B)(4). PRODUCT ID: 5630724, LOT: H5591342(X4), H5593765(X4), 510K: K191066, UDI: (B)(4). PRODUCT ID: 1608451090, LOT: 74JP(X2), 510K: K191066, UDI: (B)(4). PRODUCT ID: P1603LII, LOT: MX92811AAP (X1) PRODUCT ID: P1603MGS, LOT: CCCN19H7(X2). ALTHOUGH IT IS UNKNOWN WHETHER THESE PRODUCTS CAUSED OR CONTRIBUTED TO THE REPORTED EVENT, WE ARE FILLING THIS MDR FOR NOTIFICATION PURPOSE. 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.

    Description of Event or Problem · 1

    PRE-OP DIAGNOSIS: RECURRENT DISC HERNIATION PROCEDURE: POSTERIOR LUMBAR FUSION (PLF) NUMBER OF LEVELS TO BE TREATED: 3 LEVELS (FROM L2- S1) IT WAS REPORTED THAT POST-OP, PATIENT COMPLAINED RIGHT LEG PAIN STARTING 1 MONTH POST-OPERATIVE; WHICH RADIATED INTO RIGHT POSTEROL ATERAL THIGH, LATERAL LEG & FOOT INTO THE 3RD & 5TH TOES. PATIENT REPORTS THAT PAIN IS NOW WORSE & INCREASES WITH AMBULATION. PATIENT HAD LOWER SPINE CT W/O CONTRAST TODAY WHICH SHOWED INSTRUMENTATION IN GOOD POSITION WITH NO ACUTE FINDINGS. PAIN IS THOUGHT TO BE A NEUROPATHIC PAIN POSSIBLY FROM NERVE MANIPULATION DURING SURGERY AND SHOULD GRADUALLY RESOLVE. SPONSOR RELATEDNESS ASSESSMENT: THIS EVENT IS POSSIBLY RELATED WITH BONE MORPHOGENIC PROTIEN AND THE SURGICAL PROCEDURES. EVENT IS NOT RELATED WITH THE SURGICAL CON STRUCT/DEVICES. SITE RELATEDNESS ASSESSMENT: RELATEDNESS WITH SURGICAL CONSTRUCT AND/OR STUDY PROCEDURE- RELATED RELATEDNESS WITH SURGICAL PROCEDURE- POSSIBLE OUTCOME STATUS: PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639267 INFUSE BONE GRAFT FILLER, RECOMBINANT HUMAN BONE MORPHOGENETIC PROTEIN, COLLAGEN SCAFFOLD WITH MET NEK MEDTRONIC SOFAMOR DANEK USA, INC P1603LII MX92811AAP

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Other