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

Model Number	PDVM5
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Neck Pain (2433)
Date of Event	04/10/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient had a pdc vivo implanted on (b)(6) 2023.Patient had persistent neck pain and the surgeon suspected implant loosening.The implant was removed on (b)(6) 2024 and the patient was converted to fusion with a shoreline acdf.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a pdc vivo implant on (b)(6) 2023.Patient had persistent neck pain and the surgeon suspected implant loosening.The implant was removed on (b)(6) 2024 and the patient was converted to fusion with a shoreline acdf.A review of the dhr found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the level defined in the risk documentation.A review of the risk documentation found that the hazardous situation asociated with the complaint is identified and mitigated to a level where the clinical benefits outweigh the risks.Device evaluation could not be completed as the implant was not returned following the removal surgery.No anomalies were identified during the complaint investigation.The removal was due to the patient's neck pain, no reason for the neck pain was identified.The submission is 1 of 1 devices involved in this event.

• Brand Name: PRODISC C VIVO US IMPLANT MEDIUM 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: 19152706
• Report Number: 3007494564-2024-00031
• Device Sequence Number: 8434518
• Product Code: MJO
• UDI-Device Identifier: 00843193113672
• UDI-Public: 00843193113672
• Combination Product (Y/N): N
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2024

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 Expiration Date: 09/30/2025
• Device Model Number: PDVM5
• Device Catalogue Number: N/A
• Device Lot Number: 2020-1205R
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 04/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2023
• 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: 30 YR
• Patient Sex: Unknown