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	Malposition of Device (2616)
Health Effect - Clinical Code	Limb Pain (4836)
Date of Event	05/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient was implanted with two prodisc l devices at l4-5 and l5-s1 on (b)(6) 2026.The surgeon implanted one of the devices off of midline, but thought that it would be okay.However, the patient was experiencing leg pain.The implant was removed on (b)(6) 2026 and the patient was fused.
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient was implanted with two prodisc l devices at l4-5 and l5-s1 on (b)(6) 2026.The surgeon implanted one of the devices off of midline, but thought that it would be okay.However, the patient was experiencing leg pain.The implant was removed on (b)(6) 2026 and the patient was fused.A dhr review 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 device was not returned following the removal surgery.Therefore, no device evaluation could be completed.Additionally, no imaging was provided.There were no anomalies identified during the complaint investigation.The removal was completed because the implant was placed off of midline.The submission is 2 of 3 devices involved in this event.

• 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 EXTON; 240 sierra dr suite 100; exton PA 19341
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 25407544
• Report Number: 3007494564-2026-00057
• Device Sequence Number: 10741903
• Product Code: MJO
• UDI-Device Identifier: 00843193111708
• UDI-Public: (01)00843193111708(17)300930(10)2025-0630
• 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: 2026
• Device Explanted Year: 2026
• 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): 06/04/2026

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: 2025-0630
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/23/2025
• 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: 39 YR
• Patient Sex: Male