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

Model Number PDVLD5

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 12/28/2023

Event Type  Injury  

Event Description

Patient was implanted with three prodisc c vivo implants on (b)(6) 2023.Middle level (c5/6) of the three level construct was found to have migrated anteriorly.Migrated implant was removed on 28dec2023.Migrated implant was replaced with a prodisc c implant.

Manufacturer Narrative

An mdr is indicated for this complaint.Patient was implanted with three prodisc c vivo implants on (b)(6) 2023.Middle level (c5/6) of the three level construct was found to have migrated anteriorly.Migrated implant was removed on 28dec2023.Migrated implant was replaced with a prodisc c implant.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 hazards associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.The removed implant will be evaluated following exponent's approved prodisc c device evaluation protocol.The report will be issued under pdcv-0008.The removal was completed due to the anterior migration of the implant.A cause for the anterior migration cannot be determined but may be related to the off label use of the three level construct.This report is for 1 of 1 devices involved in this event.

• Brand Name: PRODISC C VIVO US IMPLANT LARGE-DEEP 5MM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 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
• MDR Report Key: 18520851
• MDR Text Key: 332950597
• Report Number: 3007494564-2024-00005
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843193113764
• UDI-Public: 00843193113764
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/16/2024

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
• Device Operator: Health Professional
• Device Model Number: PDVLD5
• Device Catalogue Number: N/A
• Device Lot Number: 2022-1752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Initial Date Manufacturer Received: 12/21/2023
• Initial Date FDA Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male