MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC L INFERIOR END PLATE LARGE 3-STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-L-IP03S
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A patient was implanted with two prodisc l implants at l4-5 and l5-s1 on (b)(6) 2025.After implantation x-ray imaging showed that the implants were no longer in their original positions.Patient has no symptoms at this time, so no additional medical intervention has been scheduled.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with two prodisc l implants at l4-5 and l5-s1 on (b)(6) 2025.After implantation x-ray imaging showed that the implants were no longer in their original positions.Patient has no symptoms at this time, so no additional medical intervention has been scheduled.A review of the dhrs found no anomalies associated with the complaint.Complaint trending found 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 pdl devices remain implanted within the patient therefore no device evaluation could be completed.Imaging was provided that showed the migrated implants.No anomalies were identified during the complaint investigation.A reason for the implant migration is unknown.This report is for 6 of 6 devices involved in this event.

• Brand Name: PRODISC L INFERIOR END PLATE LARGE 3-STERILE
• 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: 22794308
• Report Number: 3007494564-2025-00075
• Device Sequence Number: 8264522
• Product Code: MJO
• UDI-Device Identifier: 00843193114938
• UDI-Public: (01)00843193114938(17)280831(10)2023-0248
• 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
• 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): 08/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PDL-L-IP03S
• Device Catalogue Number: N/A
• Device Lot Number: 2023-0248
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/12/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Male