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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EATONTOWN GRAFTON DBM BONE GRAFTING MATERIAL, HUMAN SOURCE

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MEDTRONIC EATONTOWN GRAFTON DBM BONE GRAFTING MATERIAL, HUMAN SOURCE Back to Search Results
Catalog Number T44115INT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Reaction (2414)
Event Date 03/02/2019
Event Type  Injury  
Manufacturer Narrative
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. Manufacturing assessment review: five manufacturing records were reviewed and no related deviations or non conformances were observed for the batch (b)(4) and part# t44115int. Grafton crunch test reports were reviewed (base sterility, sterility, endotoxin, moisture analysis, glycerol content, calcium assay). All tests passed and no deviations or non conformances were observed. Hcp reviews: based on the information provided, doctor don¿t believe that the patient¿s outcome was not caused by the tissues implanted, as received, processed, packaged , stored and shipped by us. In other words, nothing within the control of mdt, including suitability determination by proxy through our recovery partner, contributed to any events reported from tissues secured and processed from this donor. Donor file & donor eligibility records: the donor charts revealed-no deviations from sop, supplies were in compliance and recovery was performed in time and temperature limits. Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient underwent posterolateral spinal surgery due to spinal fracture at t4, t5 and t6, where the patient had been implanted with tissue along with screws from t3 to t7. The patient was in icu for 10 days and after that the patient was transferred to hospitalization. The patient was treated with "fictriazone" and vancomycin 1 gram every 12 hours during he was in icu. On (b)(6) 2019, the patient turned yellow and water started coming out of the injured site. On (b)(6) 2019, the patient underwent revision surgery where the implanted tissue was removed and doctor washed the injured site. There was no necrosis on the walls, there was no pus, there was a granulomatous reaction on the wall and yellowish liquid. The doctor sent a sample of tissue for the culture results and a ¿gram negative bacteria¿ was found in the result on the wound site. Patient never had fever and also patient¿s immune was not compromised and he was not undergoing chemotherapy. The patient recovered few days later and discharged from hospital.
 
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Brand NameGRAFTON DBM
Type of DeviceBONE GRAFTING MATERIAL, HUMAN SOURCE
Manufacturer (Section D)
MEDTRONIC EATONTOWN
201 industrial way west
eatontown NJ 07724
Manufacturer (Section G)
MEDTRONIC EATONTOWN
201 industrial way west
eatontown NJ 07724
Manufacturer Contact
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key8468481
MDR Text Key140457079
Report Number2246640-2019-00005
Device Sequence Number1
Product Code NUN
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K051188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2021
Device Catalogue NumberT44115INT
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/01/2019 Patient Sequence Number: 1
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