MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC L INFERIOR END PLATE MEDIUM 8-STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-M-IP08S
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Unspecified Nervous System Problem (4426)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An mdr is indicated for this complaint.It was reported that a patient (female, 42 years) was implanted with a prodisc l device at l5-s1 on (b)(6) 2025.After implantation surgery the patient was experiencing neurological issues and it was found that the device was off of midline by 1.5 mm.The implant was removed on (b)(6) 2025 and the patient was fused with a cage and plate.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 hazardous situations associated with the complaint are identified and mitigated to a level where the clinical benefit outweighs the harm.The prodisc l device was not returned following the removal surgery.Therefore, no device evaluation could be completed.Additionally, no pre-removal imaging was provided.There were no anomalies identified during the complaint investigation.The removal was completed due to patient neurological symptoms caused by the device placed off of midline.The submission is 3 of 3 devices involved in this event.
Event or Problem Description
A patient (female, 42 years) was implanted with a prodisc l device at l5-s1 on (b)(6) 2025.After implantation surgery the patient was experiencing neurological issues and it was found that the device was off of midline by 1.5 mm.The implant was removed on (b)(6) 2025 and the patient was fused with a cage and plate.

• Brand Name: PRODISC L INFERIOR END PLATE MEDIUM 8-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: 24036141
• Report Number: 3007494564-2026-00003
• Device Sequence Number: 18394846
• Product Code: MJO
• UDI-Device Identifier: 00843193114976
• UDI-Public: (01)00843193114976(17)300930(10)2025-0658
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 01/08/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: PDL-M-IP08S
• Device Catalogue Number: N/A
• Device Lot Number: 2025-0658
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2025
• 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: 42 YR
• Patient Sex: Female