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

Model Number	09.820.045S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Neck Pain (2433)
Date of Event	10/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was implanted with a prodisc c device at level c4-5 on (b)(6) 2023.Patient had lingering radicular symptoms but developed an urgent swallowing issue at 7 months post op.It was determined that the implant migrated to a 90% egress of the adr.Patient was revised to an acdf on 02nov2023.
Additional Manufacturer Narrative
An mdr report is indicated for this complaint.It was reported that a patient was implanted with a prodisc c device at level c4-5 on (b)(6) 2023.Patient had lingering radicular symptoms but developed an urgent swallowing issue at 7 months post op.It was determined that the implant migrated to a 90% egress of the adr.Patient was revised to an acdf on 02nov2023.Patient is doing well following the revision.A review of the dhr was completed and no anomalies associated with the complaint were identified.Complaint trending found that the rate of complaints is within the poc level defined within the risk documentation.A review of the risk documentation found that the hazards associated with this complaint are identified and mitigated to a level where the benefits outweigh the risks.The implant was not returned following removal due to hospital pathology procedures.It was confirmed that a removal took place due to implant migration.No other anomalies associated with the complaint were found during the investigation.The cause for the migration is unknown.This report is for 1 of 1 devices involved in this event.
Event or Problem Description
Patient was implanted with a prodisc c device at level c4-5 on (b)(6) 2023.Patient had lingering radicular symptoms but developed an urgent swallowing issue at 7 months post op.It was determined that the implant migrated to a 90% egress of the adr.Patient was revised to an acdf on (b)(6) 2023.
Additional Manufacturer Narrative
An mdr report is indicated for this complaint.It was reported that a patient was implanted with a prodisc c device at level c4-5 on (b)(6) 2023.Patient had lingering radicular symptoms but developed an urgent swallowing issue at 7 months post op.It was determined that the implant migrated to a 90% egress of the adr.Patient was revised to an acdf on (b)(6) 2023.A medwatch report was received on 09aug2024 which indicated that the fusion was not successful.The failed fusion complaint will be provided to the fusion device legal manufacturer.A review of the dhr was completed and no anomalies associated with the complaint were identified.Complaint trending found that the rate of complaints is within the poc level defined within the risk documentation.A review of the risk documentation found that the hazards associated with this complaint are identified and mitigated to a level where the benefits outweigh the risks.The implant was requested to be returned after removal for device evaluaton, but the removal surgeon stated that is was unavailable for return due to hospital pathology procedures.The removal surgeon did state that the device "came out as two separate peices but nothing was obviously broken or defective".A two piece removal for this device is standard as the implant is made up of the inferior endplate with the poly inlay and the superior endplate.It was confirmed that a removal took place due to implant migration.No other anomalies associated with the complaint were found during the investigation.The cause for the migration is unknown.This report is for 1 of 1 devices involved in this event.

• Brand Name: PRODISC C 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
• MDR Report Key: 18237628
• Report Number: 3007494564-2023-00065
• Device Sequence Number: 3201418
• Product Code: MJO
• UDI-Device Identifier: 00843193112811
• UDI-Public: 00843193112811
• 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: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2024

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: 08/31/2026
• Device Model Number: 09.820.045S
• Device Catalogue Number: N/A
• Device Lot Number: 2022-0154
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2023
• Supplement Date Received by Manufacturer: 11/02/2023; Not provided
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/18/2024; 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2022
• 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: 34 YR
• Patient Sex: Male