MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC C US IMPLANT LARGE 5MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.045S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Neck Pain (2433)
Date of Event	02/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient received a large 5mm pdc implant on (b)(6) 2020.The patient was complaining of c6 root pain at the time of implantation.At 6 week follow up the patient was still complaining of c6 root pain.Imaging indicated the implant was in good position based on the revising surgeon's opinion.For unknown reasons other than persistent pain, the surgeon was asked to remove the pdc device and replace it with a fusion using an unknown fusion device.There were no known patient comorbidities or clear reason for removal in the opinion of the revising surgeon.Surgical intervention was completed on (b)(6) 2021 to remove the pdc implant and replace it with a fusion.The patient was discharged with less pain after surgery.Additional follow up status is unknown.Dhr review did not find any issues in manufacturing which may have caused or contributed to the complaint.The design fmea for this device was reviewed and concluded the associated risks are identified, mitigated, and acceptable.The device was kept by the patient at their request and not available for testing.The investigation could not determine a cause for this adverse event.
Event or Problem Description
A patient underwent a revision surgery to remove a prodisc c us implant large 5mm.The patient was initially implanted with the device on (b)(6) 2020 to address c6 root pain.The pain did not subside up to 6 week follow up when the decision to revise the patient to a fusion was made.The patient was revised on (b)(6) 2021.No complications were indicated from the revision procedure.

• Brand Name: PRODISC C US IMPLANT LARGE 5MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 11415507
• Report Number: 3007494564-2021-00014
• Device Sequence Number: 3853449
• Product Code: MJO
• UDI-Device Identifier: 00843193112811
• UDI-Public: 00843193112811
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/25/2021

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: 06/30/2022
• Device Model Number: 09.820.045S
• Device Catalogue Number: N/A
• Device Lot Number: H684579
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 03/04/2021
• 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: Required Intervention