MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC L SUPERIOR END PLATE MEDIUM 3-STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-M-SP03S
Medical Device Problem Code	Osseointegration Problem (3003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An mdr is indicated for this complaint.A patient was implanted with prodisc l on (b)(6) 2024 at level l4-5.Within 12 hours the implant had subsided into the vertebrae.The pdl implant was removed and the patient was revised to an alif on (b)(6) 2024.A review of the dhrs found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is within the levels defined in the risk documentation.A review of the risk documentation found that the risks associated with the complaint are identified and mitigated to a level where the clinical benefits of surgery outweigh the risks.Device evaluation could not be completed as the implant was not returned following the removal surgery.There were no anomalies associated with the complaint identified during the complaint investigation.The reason for the implant removal is subsidence.The submission is 1 of 3 devices involved in this event.
Event or Problem Description
A patient was implanted with prodisc l on (b)(6) 2024 at level l4-5.Within 12 hours the implant had subsided into the vertebrae.The pdl implant was removed and the patient was revised to an alif on (b)(6) 2024.

• Brand Name: PRODISC L SUPERIOR END PLATE MEDIUM 3-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: 18950122
• Report Number: 3007494564-2024-00027
• Device Sequence Number: 7078296
• Product Code: MJO
• UDI-Device Identifier: 00843193114983
• UDI-Public: 00843193114983
• 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): 03/21/2024

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-SP03S
• Device Catalogue Number: N/A
• Device Lot Number: 2023-0666
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/15/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male