MAUDE Adverse Event Report: CENTINEL SPINE, LLC PRODISC C US IMPLANT; PROSTHESIS, INTERVERTEBRAL DISC

Model Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Muscle Weakness (1967); Pain (1994)

Event Date 08/22/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that a two level pdc implantation occurred approximately (b)(6) 2023.Following implantation, the patient experienced on-going arm pain and weakness.A two level removal occurred on (b)(6) 2023 and the patient was converted to a two level acdf with a cage and plate system.The removing surgeon indicated that inadequate decompression led to the ongoing patient symptoms.A review of the dhr could not be completed as the part number and lot number were not provided and could not be determined during the investigation.Complaint trending found that the rate of complaints was within the rates outlined in the risk documentation.A review of the risk documentation found that the risks associated with the complaint are identified and mitigated to a level where the benefits of the surgery outweigh the risks.Device evaluation could not be completed as the hospital would not release the implants following the removal surgery, additionally pre-removal x-ray images were not available.No device anomalies were identified during the investigation, the removal surgery was due to ongoing patient symptoms caused by inadequate decompression during the implantation surgery.This submission is 2 of 2 devices involved in this event.

Event Description

A two level pdc implantation occurred approximately (b)(6) 2023.Following implantation, the patient experienced on-going arm pain and weakness.A two level removal occurred on (b)(6) 2023 and the patient was converted to a two level acdf with a cage and plate system.The removing surgeon indicated that inadequate decompression led to the ongoing patient symptoms.

• Brand Name: PRODISC C US IMPLANT
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): CENTINEL SPINE, LLC; 900 airport road, suite 3b; west chester PA 19380
• Manufacturer (Section G): CENTINEL SPINE, LLC; 900 airport road, suite 3b; west chester PA 19380
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878897
• MDR Report Key: 17735879
• MDR Text Key: 323271006
• Report Number: 3007494564-2023-00044
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070001
• 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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