MAUDE Adverse Event Report: CENTINEL SPINE, LLC. PRODISC L INFERIOR END PLATE LARGE 0-STERILE; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	PDL-L-IP00S
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided indicates the patient suffered a prodisc l implant migration.The migration has been linked to patient back pain, and this malfunction is likely to require surgical intervention to preclude serious injury.The actual cause or hazard resulting in the migration is unknown as the surgeon has not indicated why this may have occurred.This information led to a determination that a mdr submission is required for this event.Dhr review did not find any manufacturing issues which may have caused or contributed to this complaint.Complaint history found the rate of complaints to be acceptable.The linked complaint determined the possible cause was attributed to the surgical technique.This may have also contributed to the migration.The risk assessment determined this hazardous situation is identified and determined to be acceptable.No capas were related to this complaint.No device was removed or returned for evaluation.The prodisc l us surgical technique guide has specific instructions to perform a complete and thorough discectomy and remobilization of the disc space.This process is emphasized within the surgical technique guide to achieve motion preservation and is indicated as critical for the success of the surgery.This report is for 1 of 3 devices involved in this event.
Event or Problem Description
A patient received a pdl us implant on (b)(6) 2021.The patient has now suffered a device migration which is contributing to back pain.This type of malfunction is likely to lead to surgical intervention to correct the problem and prevent serious injury.The patient has not been scheduled for surgical intervention as of this submission.

• Brand Name: PRODISC L INFERIOR END PLATE LARGE 0-STERILE
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC.; 900 airport rd, suite 3b; west chester PA 19380
• MDR Report Key: 12221025
• Report Number: 3007494564-2021-00063
• Device Sequence Number: 11624132
• Product Code: MJO
• UDI-Device Identifier: 00843193111753
• UDI-Public: 00843193111753
• 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: 2021
• 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): 07/20/2021

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 Expiration Date: 02/28/2023
• Device Model Number: PDL-L-IP00S
• Device Catalogue Number: N/A
• Device Lot Number: H514243
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/23/2021
• 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: Required Intervention
• Patient Age: 21 YR