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	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2024
Type of Reportable Event	Malfunction
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) 2024.At a follow up appointment it was suspected that the implant was subsided.Additional imaging was requested to better visualize the device.A ct scan was completed it was confirmed that there was a fractured l5 endplate and some subsidence of the implant there.The patient is currently asymptomatic and happy with the implant.The surgeon will follow the patient with additional radiographs every 3-6 months.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 the complaint are identified and mitigated to a level where the clinical benefits outweigh the risks.The devices remains implanted within the patient, therefore no device evaluation could be completed.Imaging that showed the subsidence was not provided.The subsidence and endplate fracture were confirmed but a reason for the occurrence is unknown.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) 2024.At a follow up appointment it was suspected that the implant was subsided.Additional imaging was requested to better visualize the device.A ct scan was completed it was confirmed that there was a fractured l5 endplate and some subsidence of the implant there.The patient is currently asymptomatic and happy with the implant.The surgeon will follow the patient with additional radiographs every 3-6 months.

• 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: 20350809
• Report Number: 3007494564-2024-00074
• Device Sequence Number: 8062404
• Product Code: MJO
• UDI-Device Identifier: 00843193111760
• UDI-Public: (01)00843193111760(17)280831(10)20230282
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 09/25/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PDL-M-PT10S
• Device Catalogue Number: N/A
• Device Lot Number: 2023-0282
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/03/2023
• 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
• Patient Age: 44 YR
• Patient Sex: Male