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

Model Number	PDVL5
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/05/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A patient was implanted with a prodisc c vivo device at level c6-7 on (b)(6) 2023.The implant was removed on (b)(6) 2023.The patient was complaining about pain in both arms; with the right arm being worse than the left as the reason for the removal.X-ray images were provided.The surgeon stated that the implant placement looks perfect, but inadequate decompression may have occurred on the asymptomatic side.A review of of the device history record was conducted and found no anomalies.Complaint trending showed that the rate of complaints was at the lowest possible level of improbable.A review of the risk assessment found that the risks associated with the complaint are identified and mitigated to a level where the benefits outweigh the risks.A device evaluation could not be completed as the implant was disposed of at the hospital and not returned.No anomalies related to the complaint were found during the investigation.Based on the surgeon's comments, there was no malfunction of the device and the symptoms were likely caused by decompression that was not thorough enough.This submission is 1 of 1 devices involved in this event.
Event or Problem Description
A patient was implanted with a prodisc c vivo device at level c6-7 on (b)(6) 2023.The implant was removed on (b)(6) 2023.The patient was complaining about pain in both arms; with the right arm being worse than the left as the reason for the removal.X-ray images were provided.The surgeon stated that the implant placement looks perfect, but inadequate decompression may have occurred on the asymptomatic side.

• Brand Name: PRODISC C VIVO US IMPLANT LARGE 5MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE INC.; 900 airport road; suite 3a; west chester PA 19380
• Manufacturer (Section G): CENTINEL SPINE; 900 airport road; suite 3a; west chester PA 19380
• Manufacturer Contact: taylor donaghy ; 900 airport road; suite 3a; west chester, PA 19380 ; 4848878874
• MDR Report Key: 17173396
• Report Number: 3007494564-2023-00032
• Device Sequence Number: 12587674
• Product Code: MJO
• UDI-Device Identifier: 00843193113733
• UDI-Public: 00843193113733
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P070001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/14/2023

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 Model Number: PDVL5
• Device Catalogue Number: N/A
• Device Lot Number: 2022-1584
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2023
• Initial Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 39 YR
• Patient Sex: Male