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

Model Number	PDL-M-PT10S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Neuropathy (1983)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with a prodisc l device at l5-s1 on (b)(6) 2025.The patient was experiencing weakness in the left foot and calf following the pdl implantation.The surgeon believed that during implantation of the pdl, the keel cut dislodged some bony fragments causing the patient's symptoms.On (b)(6) 2025 the surgeon completed a revision surgery where he removed bone fragments and then fused the patient via a posterior approach using pedicle screws and rods.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with a prodisc l device at l5-s1 on (b)(6) 2025.The patient was experiencing weakness in the left foot and calf following the pdl implantation.The surgeon believed that during implantation of the pdl, the keel cut dislodged some bony fragments causing the patient's symptoms.On (b)(6) 2025 the surgeon completed a revision surgery where he removed bone fragments and then fused the patient via a posterior approach using pedicle screws and rods.A dhr review found no anomalies identified 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 prodisc l device remains implanted within the patient and was not returned, therefore, no device evaluation could be completed.Additionally, no imaging was provided.There were no anomalies identified during the complaint investigation, the revision was completed due to bone fragments from the keel cut that lead to leg weakness.The submission is 2 of 3 devices involved in this event.

• Brand Name: PRODISC L PE-INLAY W/ X-RAY MARKER, STERILE, SIZE MEDIUM, 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, 8320 ; SZ 8320
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 23837914
• Report Number: 3007494564-2025-00143
• Device Sequence Number: 14722715
• Product Code: MJO
• UDI-Device Identifier: 00843193111760
• UDI-Public: (01)00843193111760(17)300831(10)2025-0424
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2025

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-M-PT10S
• Device Catalogue Number: N/A
• Device Lot Number: 2025-0424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/16/2025
• 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: 35 YR
• Patient Sex: Female