• 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
Catalog Number T44115INT
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Seroma (2069)
Event Date 10/14/2019
Event Type  Injury  
Manufacturer Narrative
Donor file, donor eligibility records: no additional reports of adverse events for this donor was found. Recovery of the subject donor tissue was found to be 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 to the sops. The recovery was performed within the established time and temperature limits for recovery. Hcps reviews based on donor charts: this sounds like wound dehiscence, and this complication would not be caused by our product. It is a complication related to surgical wound closure. Product was not 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. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient underwent a surgery at l2-l4 due to trauma. She was implanted with screws at l2, l3, l4 and a 15cc crunch. The alleged product was placed by posterolateral approach. On (b)(6) 2019, post-op, the patient returned to doctor as the back wound did not close completely and a serious secretion was observed in the wound. The patient did not have a fever, had a culture test and was negative, had no symptoms and no infection. Hence, the patient underwent an additional surgery, in which the doctor washed the wound and closed it again.
 
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
stacie ziemba
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key9316513
MDR Text Key167952383
Report Number2246640-2019-00009
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 11/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/27/2022
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 Received10/17/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/28/2019
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: 11/13/2019 Patient Sequence Number: 1
-
-