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

Model Number PDL-L-SP03S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Spinal Column Injury (2081)

Event Date 01/15/2024

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 333960331
• Report Number: 3007494564-2024-00009
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 00843193114952
• UDI-Public: 00843193114952
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PDL-L-SP03S
• Device Catalogue Number: N/A
• Device Lot Number: 2023-0251
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female