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	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with a prodisc c implant on (b)(6) 2021 at c4-5.Patient began experiencing symptoms in line with facet pain and it was noted by the removal surgeon that the implant was too large and causing pain.Surgeon removed the implant on (b)(6) 2024 and fused the patient with a medtronic acdf device.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.A patient was implanted with a prodisc c implant on (b)(6) 2021 at c4-5.Patient began experiencing symptoms in line with facet pain and it was noted by the removal surgeon that the implant was too large and causing pain.The surgeon removed the implant on (b)(6) 2024 and fused the patient with a medtronic acdf device.A dhr review found no anomalies associated with the complaint.Complaint trending found that the rate of complaints was not within the levels outlined in the risk documentation, a cn will be completed to revise 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 removed implant was not returned from the hospital as it was sent to pathology and therefore no device evaluation could be completed.The removal was due to the implant being oversized and causing pain.The submission is 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: 19766639
• Report Number: 3007494564-2024-00049
• Device Sequence Number: 15581954
• Product Code: MJO
• UDI-Device Identifier: 00843193112767
• UDI-Public: 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: 2021
• 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): 07/16/2024

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 Expiration Date: 08/31/2024
• Device Model Number: 09.820.026S
• Device Catalogue Number: N/A
• Device Lot Number: 2020-0393
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2024
• Initial Report FDA Received Date: 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/23/2020
• 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: Female