MAUDE Adverse Event Report: CENTINEL SPINE PRODISC C VIVO OUS CURVED MEDIUM-DEEP 5MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number 04.670.935S

Device Problem Biocompatibility (2886)

Patient Problems Fatigue (1849); Fever (1858); Hypersensitivity/Allergic reaction (1907); Neck Pain (2433)

Event Date 11/28/2022

Event Type  Injury  

Event Description

A patient was implanted with a prodisc c vivo ous device at level c7 on (b)(6) 2022.Since the surgery, it's been reported the patient is having issues, which included a positive test for a titanium oxide allergy that was unknown at the time of implantation.The patient's symptoms included recurrent elevated temperatures and a general feeling of weakness, as well as intermittent pain in the nuchal area.The allergy report was provided showing the patient does have a titanium oxide allergy and the material composition document was reviewed to determine titanium oxides do exist in the implanted prodisc c vivo ous device.

Manufacturer Narrative

A patient was implanted with a prodisc c vivo ous device at level c7 on (b)(6) 2022 in switzerland.Since the surgery, it's been reported the patient is having issues, which included a positive test for a titanium oxide allergy that was unknown at the time of implantation.The patient's symptoms included recurrent elevated temperatures and a general feeling of weakness, as well as intermittent pain in the nuchal area.The allergy report was provided showing the patient does have a titanium oxide allergy and the material composition document was reviewed to determine titanium oxides do exist in the implanted prodisc c vivo ous device.The prodisc c vivo ous device is believed to be a contributor to the patient's allergic response.This information led to a determination the complaint is a reportable event requiring an mdr submission.No other submissions are required.Dhr review did not find any problems in manufacturing which may have contributed to the complaint.Complaint history found the rate of allergy to prodisc implants is improbable/negligible.The rate is within expected limits based on the risk assessment.The prodisc c vivo ous dfmea identifies allergy to implant materials as a potential risk and patient harm.The device remains implanted and is not planned/scheduled to be removed.Removal of the prodisc c vivo ous implant is not planned at this time as the patient's prior condition has improved.The prodisc c vivo ous ifu indicates that allergy to implant materials is a contraindication.The investigation determined the complaint is likely due to a patient - implant biocompatibility problem.Though rare and improbable likelihood of occurrence, some patients will be allergic to the implant materials.This condition is contraindicated in the device labeling.This situation suggests the allergy was discovered after the patient had already received the prodisc c vivo ous implant.This submission is 1 of 1 devices involved in this event.

• Brand Name: PRODISC C VIVO OUS CURVED MEDIUM-DEEP 5MM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer (Section G): CENTINEL SPINE; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer Contact: matthew crilley ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878849
• MDR Report Key: 17306659
• MDR Text Key: 318926207
• Report Number: 3007494564-2023-00034
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 04.670.935S
• Device Catalogue Number: N/A
• Device Lot Number: 2018-1175
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/15/2019
• 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: 38 YR
• Patient Sex: Female