MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC L SUPERIOR ENDPLATE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-M-SP06
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Adhesion(s) (1695); Loss of Range of Motion (2032); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient underwent a prodisc l removal surgery due to migration of the prodisc l implant.The device migrated anteriorly from the disc space.The patient was recovering as expected, but suffered a fall down stairs on an unknown date.The fall is believed to have caused the anterior migration of the device.The revising surgeon indicated concern for blood vessel adhesion to the migrated device and elected to convert the patient to a fusion.Review of the device history records found no indication of a manufacturing issue.Complaint trending determined the rate was acceptable.Review of the dfmea identified the risks associated with this adverse event.There is no indication of a new risk or new risk rate of occurrence.The device was not provided for evaluation, and was given to the patient following explantation.
Event or Problem Description
A patient underwent a prodisc l removal surgery due to anterior migration of the implant.The surgeon removed the implant due to the loss of fixation and concerns of blood vessel adhesion to the prodisc l implant.

• Brand Name: PRODISC L SUPERIOR ENDPLATE
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 10557095
• Report Number: 3007494564-2020-00029
• Device Sequence Number: 19531415
• Product Code: MJO
• UDI-Device Identifier: 00843193111791
• UDI-Public: 00843193111791
• 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: 2020
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: PDL-M-SP06
• Device Catalogue Number: N/A
• Device Lot Number: H387025
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 55 YR