MAUDE Adverse Event Report: CENTINEL SPINE PRODISC C US IMPLANT LARGE 6MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number 09.820.046S

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Neck Pain (2433)

Event Date 04/01/2022

Event Type  Injury  

Event Description

The device was implanted on (b)(6) 2021 by the implanting surgeon.Images were provided of the device prior to removal which showed the device had migrated anteriorly.The patient is experiencing pain and radicular symptoms.There was no indicated patient comorbidities or pre-existing conditions.The patient had stryker k2m ozark plate and revance c interbody devices implanted to replace the prodisc c device.The patient underwent revision and removal of a prodisc c at c4-c5 on (b)(6) 2022 by the same surgeon.The devices were removed due to patient pain and radicular symptoms.Only the explanted pdc level was fused, no other levels were treated.Surgery was completed successfully.Patient diagnosis post incident is unknown.

Manufacturer Narrative

The patient had a pdc implanted at c4-c5 on (b)(6) 2021.It was reported that a pdc implant had migrated anteriorly, which caused patient pain and radicular symptoms, the decision to remove the implant was made on (b)(6) 2022 and the removal surgery took place on (b)(6) 2022.The patient's symptoms are believed to be due to the use of an implant height that was too tall, 6 mm high implant was used which is not the shortest implant size available.The patient's symptoms and device migration led to a determination that this was a reportable adverse event.Dhr review did not find any problems in manufacturing.Complaint history found the rate of complaints was improbable.The risk associated with this complaint is identified and the complaint rate is acceptable based on the risk assessment.Device was retrieved and shipped to exponent for evaluation.The stg recommends that the smallest device height is to be used compared to adjacent healthy discs.The information suggests that the smallest height was not used.The investigation determined that a use error in patient selection and implant sizing led to the device migration which caused the patient pain and radicular symptoms.This report is for 1 of 1 devices involved in this event.

• Brand Name: PRODISC C US IMPLANT LARGE 6MM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 900 airport road; suite 3b; west chester PA 19380
• Manufacturer (Section G): SYNTHES BRANDYWINE; 1303 goshen parkway; west chester PA 19380
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380
• MDR Report Key: 14044127
• MDR Text Key: 288805231
• Report Number: 3007494564-2022-00026
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/31/2021
• Device Model Number: 09.820.046S
• Device Lot Number: H497270
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/02/2017
• 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): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male