MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC C VIVO US IMPLANT MEDIUM-DEEP 5M; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDVMD5
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient (42yo, female) was implanted with a pdc vivo device at c5-6 on (b)(6) 2026.No information on patient symptoms was provided.However, it was stated that the posterior area may not have been addressed well enough and additionally that the implant was removed on (b)(6) 2026 and the patient was converted to a three level fusion so there may have been other affected levels.However, no reason for removal was confirmed.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a pdc vivo device at c5-6 on (b)(6) 2026.No information on patient symptoms was provided.However, it was stated that the posterior area may not have been addressed well enough and additionally that the implant was removed on (b)(6) 2026 and the patient was converted to a three level fusion so there may have been other affected levels.However, no reason for removal was confirmed.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 harms.The implant was not returned following the removal surgery therefore no device evaluation could be completed.Imaging was provided that showed the implant prior to removal.There were no anomalies associated with the complaint identified during the complaint investigation.The removal was completed do to the therapy device not being effective.This submission is 1 of 1 devices involved in this event.

• Brand Name: PRODISC C VIVO US IMPLANT MEDIUM-DEEP 5M
• 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, che 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 25124277
• Report Number: 3007494564-2026-00046
• Device Sequence Number: 10694332
• Product Code: MJO
• UDI-Device Identifier: 00843193113702
• UDI-Public: (01)00843193113702(17)281031(10)2023-1060
• 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: 2026
• Device Explanted Year: 2026
• 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): 05/07/2026

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: PDVMD5
• Device Catalogue Number: N/A
• Device Lot Number: 2023-1060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/09/2023
• 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: 42 YR
• Patient Sex: Female