MAUDE Adverse Event Report: CENTINEL SPINE, LLC. STALIF C CAGE, 14MM X 9.5MM, TAPERED; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number C146551-3T

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Foreign Body Sensation in Eye (1869); Swollen Glands (2092)

Event Type  Injury  

Manufacturer Narrative

The information provided to centinel spine has been direct from the patient.The patient believes the symptoms coincide with implantation of the stalif c device.Additional unspecified testing and treatment has led the patient to believe the stalif c device is causing an allergic reaction per the patient.The symptoms originated after the stalif c implantation and have progressively worsened over time.There has been no specific information to confirm or deny the cause/contribution of these symptoms is due to the stalif c cage or screws.The patient's own research suggested a peek allergy was possible, and that the timing of the symptoms coincides with the stalif c implantation.The patient has had about 15 spinal surgeries which include titanium products.An allergic reaction to titanium seems unlikely as none of these previous surgeries have generated these symptoms.The patient also has a bone stimulator implanted (not a centinel device).The materials from this implant were provided for allergy testing.Information from the peek raw material manufacturer suggests there have been no confirmed allergic reactions to the peek material used to manufacture stalif c cages.The material has been used to manufacture over 9 million implantable devices.There has been limited confirmation of symptoms relating to the stalif c cage and screws from a healthcare professional.The patient is currently under the care of an allergist and undergoing allergy testing.The results of the testing have not yet been provided to centinel; however, centinel has agreed to provide material samples to help the patient receive allergy testing.If results are provided, this submission may be updated.

Event Description

Patient contacted centinel spine indicating they received a 2-level stalif c cage and abo screws in 2017.After the procedure, the patient had local inflammation, swelling, and oozing.The patient was hospitalized and treated with antibiotics.After that incident the patient has had progressively worsening symptoms including tiny fibers in their saliva, thick sticky saliva, and tumors developing within their saliva glands.The patient indicated the tumors were confirmed via ct scan.The patient indicated they have burning mouth syndrome as well.The information provided was direct from the patient.The patient has alleged the cause of the symptoms has been attributed to the stalif c implantation and an allergic reaction to the peek material used to produce the stalif c cage.This information has not been substantiated by allergy testing at the time of this submission.

Manufacturer Narrative

The patient's allergist provided new information indicating the patient did not test positive for an allergic reaction to the materials used to manufacture the stalif c cage or stalif c abo screws implanted in the patient.No other information has been made available to determine the cause of the patient's symptoms.The allergist indicated all patch tests were negative on (b)(6) 2019.

Event Description

Follow up 1 august 19, 2019: patient's allergy testing has all come back negative for the materials used to manufacture centinel's stalif c cage and abo screws.No further details were provided by the patient's allergist.No further information was provided by the patient.No direct link can be established between the patient's described symptoms and the centinel spine devices.

• Brand Name: STALIF C CAGE, 14MM X 9.5MM, TAPERED
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 8865506
• MDR Text Key: 153836981
• Report Number: 3007494564-2019-00008
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• PMA/PMN Number: K133200
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/19/2019

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: 07/31/2019
• Device Model Number: C146551-3T
• Device Lot Number: 2016-199
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/06/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 60 YR