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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 T43110INT
Device Problem Device Appears to Trigger Rejection (1524)
Patient Problem Discomfort (2330)
Event Type  Injury  
Manufacturer Narrative
Product was not returned to the manufacturer for evaluation. Therefore, we are unable to determine the definitive cause of the reported event. Hcps review based on donor records: after reviewing the donor records, and the complaint of the surgeon, the hcps see no objective evidence that the graft was the cause of the patient¿s ¿relapse¿. The fact that there was ¿no post-op infection, or immunological or inflammatory response¿ reinforces their conclusion. Manufacturing assessment: no deviations from established procedures were noted that may have increased the risk of contamination/cross contamination. All supplies and reagents utilized were inspected upon receipt and prior to recovery. The supplies and reagents were stored as per packaging or manufacturer recommendation in a temperature controlled environment. Products from multiple manufacturers were implanted during the procedure. Although it is unknown if any of the devices 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 laminectomy and posterior arthrodesis at l4-l5. During the surgery, the surgeon placed 10 cc putty into the patient. No cage was used; the surgeon only put screws and rod manufactured by medi implants. No intra-operative complications were reported. Approximately a week after the surgery, reportedly, the patient had a relapse and had low levels of saturation among other symptoms. The patient reported experiencing a rare feeling. The surgeon planned a revision surgery due to this event. On (b)(6) 2019, the revision surgery was performed. When the wound was opened, it was observed that the graft had a black-gray color and had an abnormal appearance. The surgeon then commented that the graft was bad and that the patient's body could have rejected the graft. Hence, everything implanted during the initial surgery was completely explanted. The items that were explanted included the reported graft, the screws and the rod. The patient had to be hospitalized due to this event. There was no post-op infection, or immunological or inflammatory response reported. Patient issue has been reported to be resolved.
 
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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 Key9122085
MDR Text Key162313984
Report Number2246640-2019-00008
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 09/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/16/2022
Device Catalogue NumberT43110INT
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 Received08/27/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/17/2019
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: 09/26/2019 Patient Sequence Number: 1
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