• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC EATONTOWN GRAFTON DBM BONE GRAFTING MATERIAL, HUMAN SOURCE Back to Search Results
Model Number T43102JPN
Device Problem Device Appears to Trigger Rejection (1524)
Patient Problems Inflammation (1932); Quadriplegia (2449)
Event Date 11/30/2020
Event Type  Injury  
Manufacturer Narrative
Donor file, donor eligibility records: the donor charts revealed no additional reports of adverse reactions involving any other organs/tissues recovered from this donor. Recovery of the subject donor tissue was performed using a method appropriate to controlling contamination. There were no deviations from established procedures that may have increased the risk of contamination/cross contamination. All supplies and reagents used during the recovery were in compliance with (b)(4). The recovery was performed within the established time and temperature limits for recovery. Hcp reviews: after reviewing the chart and the processing report that revealed no nonconformities, our tissue was not the cause of the patients surgical complication. Furthermore, there is no evidence to suggest that an antibody response was the source of the complication. 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
Information was received from a health care facility via a manufacturer representative regarding a patient with congenital diaphragmatic hernia (cdh) for anterior cervical discectomy and fusion (alif) spinal therapy. It was reported that the it was an inflammatory reaction caused by the human origin of graft and patient did not achieve solid fusion because it was one month after the operation, the cage was replaced with a new one. The patient had temporary quadriplegia symptoms reported. Mri confirmed that inflammatory exudate appeared in the spinal canal. Quadriplegia occurred due to an inflammatory reaction occurred one month after the operation on (b)(6), but steroid and antibiotic disappeared for 2 days. Most likely inflammatory exudate. The physician said that it was antibody response of protein, etc. Of human origin. There were no further complications reported regarding the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10990992
MDR Text Key220900022
Report Number2246640-2020-00006
Device Sequence Number1
Product Code NUN
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K051188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberT43102JPN
Device Catalogue NumberT43102JPN
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 Received08/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/17/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/11/2020 Patient Sequence Number: 1
-
-