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

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

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.

Manufacturer Narrative

Corrected information: sex.If information is provided in the future, a supplemental report will be issued.

• Brand Name: GRAFTON DBM
• Type of Device: BONE 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 Key: 6217069
• MDR Text Key: 63688591
• Report Number: 2246640-2017-00001
• Device Sequence Number: 1
• Product Code: NUN
• UDI-Device Identifier: 00643169123175
• UDI-Public: 00643169123175
• Combination Product (y/n): N
• PMA/PMN Number: K051188
• Number of Events Reported: 1
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/03/2018
• Device Catalogue Number: T43102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/02/2017
• Supplement Dates Manufacturer Received: 12/21/2016
• Supplement Dates FDA Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/13/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 45 YR