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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OSTEOTECH. INC GRAFTON DBM BONE GRAFTING MATERIAL, HUMAN SOURCE

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OSTEOTECH. INC GRAFTON DBM BONE GRAFTING MATERIAL, HUMAN SOURCE Back to Search Results
Catalog Number T43102
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Skin Discoloration (2074); Swelling (2091)
Event Type  Injury  
Manufacturer Narrative
Corrected information: sex. If information is provided in the future, a supplemental report will be issued.
 
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.
 
Event Description
It was reported that on an unknown date in (b)(6) 2015, patient underwent a surgery where titanium plate and screws were implanted at levels c4-5 and c5-6. Reportedly, post-op, patient had swelling on his neck, rheumatoid arthritis and auto-immune disease. Reportedly, ¿patient cannot work anymore and his skin near neck has turned red. ¿ patient also has a tumor. Allergy test revealed that the patient is allergic to nickel and chromium. The doctors do not know what the symptoms are related to and now are looking at the devices to see if he might be allergic to the devices.
 
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Brand NameGRAFTON DBM
Type of DeviceBONE GRAFTING MATERIAL, HUMAN SOURCE
Manufacturer (Section D)
OSTEOTECH. INC
201 industrial way west
eatontown NJ 07724
Manufacturer (Section G)
OSTEOTECH. INC
201 industrial way west
eatontown NJ 07724
Manufacturer Contact
greg anglin
1800 pyramid place
memphis, TN 38132
9013963133
MDR Report Key6217070
MDR Text Key248264164
Report Number2246640-2017-00002
Device Sequence Number1
Product Code NUN
Combination Product (y/n)N
PMA/PMN Number
K051188
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial,Followup
Report Date 12/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/02/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/03/2018
Device Catalogue NumberT43102
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/13/2015
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: 01/02/2017 Patient Sequence Number: 1
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