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

Model Number	PDVXL5
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
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 prodisc c vivo implants at levels c5-6 and c6-7 on (b)(6) 2024.Patient was asymptomatic and at a routine follow up it was found that the bottom level had migrated.Surgeon removed both implants on (b)(6) 2024 and fused the patient.A dhr review 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 vivo devices were not returned following the removal surgery, therefore no device evaluation could be completed.Imaging was provided that confirmed the implant migration.The implant removals occurred due to implant migration.The submission is 2 of 2 devices involved in this event.
Event or Problem Description
Patient was implanted with two prodisc c vivo implants at levels c5-6 and c6-7 on (b)(6) 2024.Patient was asymptomatic and at a routine follow up it was found that the bottom level had migrated.Surgeon removed both implants on (b)(6) 2024 and fused the patient.

• Brand Name: PRODISC C VIVO US IMPLANT XL 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: 20929529
• Report Number: 3007494564-2024-00098
• Device Sequence Number: 8391314
• Product Code: MJO
• UDI-Device Identifier: 00843193113795
• UDI-Public: (01)00843193113795(17)281130(10)2023-1465
• 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): 12/13/2024

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: PDVXL5
• Device Catalogue Number: N/A
• Device Lot Number: 2023-1465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/16/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2023
• 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: 50 YR
• Patient Sex: Male