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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
Model Number T43105
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Inflammation (1932); Pain (1994)
Event Date 07/14/2021
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. Although it is unknown if the device contributed to the reported event, we are filing this mdr for notification purposes. Hcps reviews based on donor charts: medical director reviewed the donor chart, and the tro answers to the relevant questions, and he believe that the complaint is unrelated to tissues as received, processed, stored and distributed by medtronic. In compliance with fda guidance on investigation of adverse reactions related to hct/ps, can you please confirm the following for this donor: any additional reports of adverse reactions involving any other organs/tissues recovered from this donor; none. Recovery of the subject donor tissue was performed using a method appropriate to controlling contamination; yes. There were no deviations from established procedures that may have increased the risk of contamination/cross contamination; no deviations from procedures. All supplies and reagents used during the recovery were in compliance with 21cfr1271. 210; yes. The recovery was performed within the established time and temperature limits for recovery. Yes. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The information was received from health care provider via a manufacturing representative regarding a patient with spinal stenosis f or posterolateral 2 level lumbar tlif spinal fusion therapy. It was reported that patient had a bad inflammatory response at the site of the graft. Patient had back pain, doctor admitted patient to hospital and removed all the graft. The revision surgery was conducted on (b)(6) 2021. There was no infection suspected, present, or treated. The patient didn't achieve solid fusion. There was no further information reported.
 
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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
david gustafson
1800 pyramid place
memphis, TN 38132
7635149628
MDR Report Key12352252
MDR Text Key267625430
Report Number2246640-2021-00004
Device Sequence Number1
Product Code NUN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberT43105
Device Catalogue NumberT43105
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 Received07/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/27/2021
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: 08/23/2021 Patient Sequence Number: 1
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