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U.S. Department of Health and Human Services

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

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MEDTRONIC EATONTOWN GRAFTON PLUS DBM BONE GRAFTING MATERIAL, HUMAN SOURCE Back to Search Results
Model Number T45010AUS
Device Problem Failure to Osseointegrate (1863)
Patient Problems Inadequate Osseointegration (2646); No Known Impact Or Consequence To Patient (2692)
Event Date 08/08/2020
Event Type  malfunction  
Manufacturer Narrative
Device is not marketed in us, however a similar device with product id# t45010, 510(k)#: k043048, udi#: (b)(4). 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 five manufacturing records were reviewed, and no deviations were observed. No nonconformance¿s or roars were observed for the batch a43975-034 and part# t45010aus. Test reports were reviewed (med cleaning of whole donors that will not yield soft tissue, base processing router, bulk tissue grinding router, grafton paste reaction router and paste syringe core packaging router). All tests passed and no deviations or non-conformances were observed. Hcps reviews: in hcps opinion, the adverse event was most likely due to surgical technique. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a health care provider via a manufacturer representative regarding a patient with cervical degeneration for spinal fusion therapy at c3-t2. It was reported that some of the paste was removed during the revision surgery, as it appeared that it wasn't fusing to the bone. The product will not be returned. There was no post-op infection, or immunological or inflammatory response. There were no further complications reported regarding the event.
 
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Brand NameGRAFTON PLUS 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
tricha miles
1800 pyramid place
memphis, TN 38132
7635140379
MDR Report Key10464550
MDR Text Key206558684
Report Number2246640-2020-00004
Device Sequence Number1
Product Code NUN
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
SEE H10
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 08/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberT45010AUS
Device Catalogue NumberT45010AUS
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/26/2020
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: 08/28/2020 Patient Sequence Number: 1
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