MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC L PE-INLAY W/ X-RAY MARKER, STERILE, SIZE LARGE, 10MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-L-PT10S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a prodisc l implant at level l5-s1 on (b)(6) 2025.The patient presented to the clinic for their 6 month follow up and imaging was completed.Although no acute injury occurred and patient is asymptomatic, the imagining showed that the implant had expulsed from the vertebral bodies.A removal has been scheduled for (b)(6) 2026.A review of the dhrs found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the level outlined 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 harms.The devices remain implanted in the patient and will not be removed until (b)(6) 2026.At that time it will be requested that the devices be returned for evaluation.An image was provided that showed the migrated implant.There were no anomalies identified during the complaint investigation.The removal will be completed due to the implant migration.The submission is 2 of 3 devices involved in this event.
Event or Problem Description
A patient (47-year-old, male) was implanted with a prodisc l implant at level l5-s1 on (b)(6) 2025.The patient presented to the clinic for their 6 month follow up and imaging was completed.Although no acute injury occurred and patient is asymptomatic, the imagining showed that the implant had expulsed from the vertebral bodies.A removal has been scheduled for (b)(6) 2026.

• Brand Name: PRODISC L PE-INLAY W/ X-RAY MARKER, STERILE, SIZE LARGE, 10MM
• 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, che 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 25124409
• Report Number: 3007494564-2026-00048
• Device Sequence Number: 8635044
• Product Code: MJO
• UDI-Device Identifier: 00843193111708
• UDI-Public: (01)00843193111708(17)300630(10)2025-0422
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2026
• 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
• Report Date (Section B): 06/16/2026

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: PDL-L-PT10S
• Device Catalogue Number: N/A
• Device Lot Number: 2025-0422
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/08/2026
• Supplement Report FDA Received Date: 06/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/14/2025
• 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: 47 YR
• Patient Sex: Male