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

Model Number	PDL-L-SP03S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Spinal Column Injury (2081)
Date of Event	01/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An mdr is indicated for this complaint.Patient had a prodisc l implant placed at the l4-5 level on (b)(6) 2023.A few weeks postop it was found that the l5 vertebrae had retrolisthesed making the implant look malpositioned.A revision surgery was completed on (b)(6) 2024.Surgeon added posterior screws at the level.Patient did not experience any symptoms.A review of the dhrs found no anomalies associated with the complaint.Complaint trending found that the rate of complaints is at the lowest possible level of improbable.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 outweigh the risks.Device evaluation could not be completed as the pdl device remains implanted within the patient.No anomalies were identified during the complaint investigation.The revision was completed because the vertebrae retrolisthesed.The cause for the vertebrae having retrolisthesed is unknown.The submission is 1 of 3 devices involved in this event.
Event or Problem Description
A prodisc l revision was completed on (b)(6) 2024.The surgeon made the decision to add posterior screws at the pdl level.

• Brand Name: PRODISC L SUPERIOR END PLATE LARGE 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
• MDR Report Key: 18594877
• Report Number: 3007494564-2024-00009
• Device Sequence Number: 18188464
• Product Code: MJO
• UDI-Device Identifier: 00843193114952
• UDI-Public: 00843193114952
• 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: 2023
• 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): 01/26/2024

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-L-SP03S
• Device Catalogue Number: N/A
• Device Lot Number: 2023-0251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/18/2024
• Initial Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• 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: 79 YR
• Patient Sex: Female