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

Model Number	PDL-M-SP03S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient was implanted with the prodisc l device on (b)(6) 2023 at the l5/s1 level due to a primary diagnosis of lumbar degenerative joint disease.The implant was removed on (b)(6) 2023.The reason for the removal was posterior migration of the implant.The removal surgery went smoothly and without issue.No further information or imaging was provided by the distributor or surgeon.The patient was fused using an unknown device at the l5/s1 level after the prodisc l device was removed.
Additional Manufacturer Narrative
It was reported that the patient was implanted with a prodisc l implant on (b)(6) 2023 at the l5-s1 level due to a primary diagnosis of lumbar degenerative joint disease.The implant was removed on (b)(6) 2023 due to posterior migration of the implant.The removal surgery went smoothly and without issue.No further information or imaging was provided by the distributor or surgeon.The patient was fused using an unknown device at the l5/s1 level after the prodisc l device was removed.Complaint trending found that the rate of complaints is within the levels defined in the risk documentation.A review of the risk assessment found that the risks associated with the complaint are identified and mitigated to a level where the benefits outweigh the risks.The removed implant was sent to exponent for device evaluation per their standard pdl evaluation process.There were no anomalies identified during the complaint investigation.Therefore, the complaint investigation did not identify a cause for the posterior implant migration which led to the removal surgery.This report is for 1 of 3 devices involved in this event.

• Brand Name: PRODISC L SUPERIOR END PLATE MEDIUM 3 DEGREES
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE; 900 airport road; suite 3b; west chester 19380
• Manufacturer (Section G): CENTINEL SPINE; 900 airport road; suite 3b; west chester 19380
• Manufacturer Contact: matthew crilley ; 900 airport road; suite 3b; west chester 19380 ; 4848878849
• MDR Report Key: 17376056
• Report Number: 3007494564-2023-00035
• Device Sequence Number: 6384470
• Product Code: MJO
• UDI-Device Identifier: 00843193114969
• UDI-Public: 00843193114969
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P050010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 07/20/2023

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: 2022-0976
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 95 KG