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

Catalog Number	T43102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rheumatoid Arthritis (1724); Autoimmune Disorder (1732); Skin Discoloration (2074); Swelling (2091)
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional Manufacturer Narrative
Corrected information: sex.If information is provided in the future, a supplemental report will be issued.

• Brand Name: GRAFTON DBM
• Common Device Name: BONE GRAFTING MATERIAL, HUMAN SOURCE
• Manufacturer (Section D): OSTEOTECH. INC; 201 industrial way west; eatontown NJ 07724
• MDR Report Key: 6217070
• Report Number: 2246640-2017-00002
• Device Sequence Number: 998138
• Product Code: NUN
• UDI-Device Identifier: 00643169123175
• UDI-Public: 00643169123175
• Combination Product (Y/N): N
• PMA/510(K) Number: K051188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2018
• Device Catalogue Number: T43102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/21/2016
• Supplement Date Received by Manufacturer: 12/21/2016
• Initial Report FDA Received Date: 01/02/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 45 YR