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

Model Number PDL-M-SP03S

Device Problem Expulsion (2933)

Patient Problem Pain (1994)

Event Date 04/26/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that the patient was implanted with a prodisc l implant on (b)(6) 2023 at l5-s1 level.Approximately two weeks after the implantation surgery the patient reported hearing and feeling a popping noise in her lumbar spine.X-ray images showed that the superior end plate appears to have dislodged anteriorly.The implant was removed on (b)(6) 2023.The pdl device was replaced with a bone alif with screws and washers and subsequent fixation was performed.A review of the dhrs found no anomalies associated with the complaint.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 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.The cause for the implant to migrate / dislodge anteriorly is unknown.This report is for 3 of 3 devices involved in this event.

Event Description

The patient was implanted with a prodisc l implant on (b)(6) 2023 at l5-s1 level.Approximately two weeks after the implantation surgery the patient reported hearing and feeling a popping noise in her lumbar spine.X-ray images showed that the superior end plate appears to have dislodged anteriorly.The implant was removed on (b)(6) 2023.The pdl device was replaced with a bone alif with screws and washers and subsequent fixation was performed.

• Brand Name: PRODISC L SUPERIOR END PLATE MEDIUM 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): HAMMILL MANUFACTURING COMPANY; 360 tomahawk drive; maumee OH 43537
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 16991529
• MDR Text Key: 315841033
• Report Number: 3007494564-2023-00029
• Device Sequence Number: 1
• Product Code: MJO
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PDL-M-SP03S
• Device Catalogue Number: N/A
• Device Lot Number: 2022-0810
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/09/2022
• 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: 48 YR
• Patient Sex: Female