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	Malposition of Device (2616)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/05/2026
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 device at l5-s1 on (b)(6) 2026.The patient felt tipped forward and it was found that the device was kyphotic.A revision was completed on (b)(6) 2026 and the superior endplate was repositioned a little deeper which seemed to correct the kyphosis.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 this complaint are identified and mitigated to a level where the clinical benefits outweigh the harms.The prodisc l implant was not returned as the plate was repositioned in the patient, no device evaluation could be completed.Additionally, no imaging was provided that showed the placement of the implant.There were no anomalies identified during the course of the complaint investigation.The revision surgery was completed due to the implant being placed too posteriorly.The submission is 2 of 3 devices involved in this event.
Event or Problem Description
A patient was implanted with a prodisc l device at l5-s1 on (b)(6) 2026.The patient felt tipped forward and it was found that the device was kyphotic.A revision was completed on (b)(6) 2026 and the superior endplate was repositioned a little deeper which seemed to correct the kyphosis.

• 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 EXTON; 240 sierra drive; exton, pa 19341 ; SZ 19341
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 24690322
• Report Number: 3007494564-2026-00024
• Device Sequence Number: 10042463
• Product Code: MJO
• UDI-Device Identifier: 00843193111760
• UDI-Public: (01)00843193111760(17)301031(10)2025-0740
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 03/24/2026

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-M-PT10S
• Device Catalogue Number: N/A
• Device Lot Number: 2025-0740
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2025
• 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 Sex: Unknown