MAUDE Adverse Event Report: 1800 PYRAMID PLACE

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

Devices of multiple part/lot numbers were implanted during the procedure including: part: unknown screw/ lot: unk (x1) part: 6288044 / lot: unk (x1) although it is unknown if any of these devices contributed to the reported event, we are filing this mdr for notification purposes.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: patient underwent a surgery at c4-5 and c5-6 on an unknown date in (b)(6) 2015 where titanium plate and screws were implanted along with demineralized bone matrix putty.It was reported that on an unknown date, post-op, patient experienced swelling in neck, rheumatoid arthritis and auto-immune disease.Reportedly, ¿patient cannot work anymore and the skin near neck has turned red.¿ patient also alleges having a tumor.Allergy test revealed that the patient is allergic to nickel and chromium.According to the report, the doctors do not know what the symptoms are related to and now are looking at the devices to see if the patient might be allergic to the devices.

Manufacturer Narrative

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

• Manufacturer (Section D): 1800 PYRAMID PLACE; memphis TN 38132
• Manufacturer (Section G): 1800 PYRAMID PLACE; memphis TN 38132
• Manufacturer Contact: greg anglin ; 1800 pyramid place; memphis, TN 38132 ; 9013963133
• MDR Report Key: 6217734
• MDR Text Key: 63694173
• Report Number: 1030489-2017-00013
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• 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: 12/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: No
• 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