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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
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 implant at l4/5 on (b)(6) 2024, pdl was placed below a fused level, the fusion was also completed on (b)(6) 2024.After surgery it was found that the implant was off of midline 4-5mm laterally.The surgeon revised the patient and corrected placement of the implant in a second surgery on the same day.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 harms associated with the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.A device evaluation could not be completed as during the revision surgery the implant position was corrected and the device remained implanted in the patient.No imaging was provided to show the implant off of midline.No anomalies associated with the complaint were identified during the investigation.The revision surgery was completed due to the device being placed off of midline, which was likely due to surgical technique.The submission is 2 of 3 devices involved in this event.
Event or Problem Description
A patient was implanted with a prodisc l implant at l4/5 on (b)(6) 2024, pdl was placed below a fused level, the fusion was also completed on (b)(6) 2024.After surgery it was found that the implant was off of midline 4-5mm laterally.The surgeon revised the patient and corrected placement of the implant in a second surgery on the same day.

• 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 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: 21149474
• Report Number: 3007494564-2025-00004
• Device Sequence Number: 9097563
• Product Code: MJO
• UDI-Device Identifier: 00843193111708
• UDI-Public: (01)00843193111708(17)290531(10)2023-1511
• 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: 2024
• Device Explanted Year: 2024
• 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): 01/13/2025

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-L-PT10S
• Device Catalogue Number: N/A
• Device Lot Number: 2023-1511
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/19/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/17/2024
• 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: 64 YR
• Patient Sex: Male