BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRAFTON DBM

    MDR report key: 8325390 · Received February 11, 2019

    Report

    Report Number
    2246640-2019-00001
    Event Type
    Injury
    Date Received
    February 11, 2019
    Date of Event
    November 28, 2018
    Report Date
    February 25, 2019
    Manufacturer
    OSTEOTECH. INC
    Product Code
    NUN
    UDI-DI
    00643169965003
    PMA / PMN Number
    K051188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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.

    Description of Event or Problem · 0

    DATE REQUEST FOR TISSUE: (B)(6) 2018 THE PATIENT FROM THE BEGINNING CAME WITH HEALTH PROBLEMS DIFFERENT FROM HER COLUMN. ACCORDING TO THE DOCTOR'S CONCEPT, THE BONE MATRIX HAD NOTHING TO DO WITH THE INFECTION. SURGEON SAYS THAT IT IS THE ACCUMULATION OF DIFFERENT EVENTS THAT LED TO THE STATE OF INFECTION OF THE PATIENT. SURGEON TELLS US THAT AFTER IDENTIFYING THE INFECTION, ALL OF THE MOS IS REMOVED AND TREATED WITH ANTIBIOTICS, BUT SOON AFTER SURGEON DID NOT SPECIFY WHEN, A BONE SUBSTITUTE WAS IMPLANTED WITH AN ANTIBIOTIC WHICH APPARENTLY DID NOT WORK AND THE INFECTION INCREASED. SURGICAL PROCEDURE: CHANNEL LUMBAR NARROW + GRAFT BONE IN SPINAL COLUMN VIA BACK DESCRIPTION OF WOUND SITE: PATIENT IS SUBMITTED FOR INFECTION OF THE LUMBAR ARRODESIS POSTERIOR L4, L5 AND L5 S1 OPERATION SITE, PLUS LAMINECTOMY WITH SCREENING AND EXPLORATION OF SIDE RAQUIDEO CHANNEL FOR BILATERAL FORAMINOTOMIAS AND LUMBAR DISC EXCISION PLUS MATRIX APPLICATION OSEA IN ANTERIOR AND POSTERIOR LUMBAR COLUMN MADE IN THE INSTITUTION, PRESENTS ISO DISCITE DISCITES, ANTIBIOTIC HANDLING IS INSTANTED, HAS REQUIRED REPLACEMENT OF VAC SYSTEM BY PART OF COLUMN SURGERY.

    Additional Manufacturer Narrative · 1

    AS PER THE HCP REVIEW IT WAS UNLIKELY THAT THE PRODUCT CAUSED THE INFECTION. MANUFACTURING ASSESSMENT- THE NON-CONFORMANCE DATABASE WAS REVIEWED AND THERE WERE NO NON-CONFORMANCES FOUND FOR (B)(4)/T43110INT. THE DONOR CHARTS REVEALED-NO DEVIATIONS FROM SOP, SUPPLIES WERE IN COMPLIANCE AND RECOVERY WAS PERFORMED IN TIME AND TEMPERATURE LIMITS. 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

    PROCEDURE: LUMBAR ARTHRODESIS, LAMINECTOMY WITH DECOMPRESSION, LATERAL SPINAL CANAL SCAN FOR FORAMINOTOMY BILATERAL, LUMBAR DISC EXCISION, DEMINERALIZED BONE MATRIX APPLICATION IN ANTERIOR AND POSTERIOR LUMBAR SPINE LEVEL IMPLANTED: L4-L5/L5-S1 IT WAS REPORTED THAT POST-OP, PATIENT HAD INFECTION ON THE OPERATING SITE REQUIRING SURGICAL MANAGEMENT AND VAC IMPLANT. PATIENT CURRENTLY IS IN TREATMENT FOR THE INFECTION WITH ANTIBIOTICS. PATIENT WAS ON ANTIBIOTICS AT THE TIME OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123024 GRAFTON DBM BONE GRAFTING MATERIAL, HUMAN SOURCE NUN OSTEOTECH. INC NA NA 00643169965003

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other| R