MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC C US IMPLANT MEDIUM 6MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	09.820.026S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	11/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient (33yo, female) was implanted with a prodisc c implant at c5-6 on (b)(6) 2024.Patient had difficulty swallowing and it was found that the implant had expulsed.Surgeon removed the implant and fused the patient on (b)(6) 2024.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient (33yo, female) was implanted with a prodisc c implant at c5-6 on (b)(6) 2024.Patient had difficulty swallowing and it was found that the implant had expulsed.Surgeon removed the implant and fused the patient on (b)(6) 2024.A review of the dhr could not be completed because the lot number of the implant was not provided and could not be determined during the course of the investigation.Complaint trending found that the rate of complaints is within the levels outlined in the risk documentation.A review of the risk documentation found that the harms associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.The implant was not returned following the removal surgery; therefore, no device evaluation could be completed.Imaging was provided that showed the expulsed implant.The implant was removed due to migration / expulsion, a cause for the migration is unknown.This report is for 1 of 1 devices involved in this event.

• Brand Name: PRODISC C US IMPLANT MEDIUM 6MM
• 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: 20786438
• Report Number: 3007494564-2024-00089
• Device Sequence Number: 7894655
• Product Code: MJO
• UDI-Device Identifier: 00843193112767
• UDI-Public: (01)00843193112767
• 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): 11/25/2024

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: 09.820.026S
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2024
• Initial Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 33 YR
• Patient Sex: Female