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

Model Number	PDVL5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/02/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with two pdc vivo implants at c5-6 and c6-7 on (b)(6) 2024.The patient had ongoing radiculopathy.A one level pdc vivo removal was completed on (b)(6) 2024.Patient was converted to a cage and plate system.No device issues were seen.A review of the dhr found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the level outlined in the risk documentation.A review of the risk documentation found that the hazards associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.The removed implants will be evaluated following exponent's approved prodisc c device evaluation protocol.The report will be issued under pdcv-0018.The removal was completed due to the therapy device not being effective and ongoing radiculopathy.A reason that the device wasn't effective is unknown.This submission is 1 of 1 devices involved in this event.
Event or Problem Description
A patient was implanted with two pdc vivo implants at c5-6 and c6-7 on (b)(6) 2024.The patient had ongoing radiculopathy.A one level pdc vivo removal was completed on (b)(6) 2024.Patient was converted to a cage and plate system.No device issues were seen.

• Brand Name: PRODISC C VIVO US IMPLANT LARGE 5MM
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC; 900 airport road, suite 3b; west chester PA 19380
• Manufacturer (Section G): FRUH VERPACKUNGSTECHNIK AG; allmendstrasse 47; fehraltorf, 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 20042435
• Report Number: 3007494564-2024-00063
• Device Sequence Number: 18142136
• 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: 2024
• Device Explanted Year: 2024
• 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): 08/21/2024

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: 2024-0383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/13/2024
• 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 Sex: Unknown