MAUDE Adverse Event Report: CENTINEL SPINE, LLC STALIF C CAGE 3 SCREW TAPERED; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 12/29/2022

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient was scheduled for a stalif c removal on (b)(6) 2022.After the surgical date it was reported that the implant "was not removed, they took a different direction".No further information was provided on the patient's condition, symptoms, or any surgical or medical treatments rendered.A review of the dhr could not be completed as the lot number and part number were not provided.Complaint trending found that the rate of complaints is at the lowest possible rate of improbable.A review of the risk assessment found that the harm associated with this complaint is identified and mitigated to an acceptable level.A device evaluation could not be completed as the stalif c cage remains implanted within the patient.A reoperation occurred, the reason for reoperation was not provided.There were no anomalies found during the investigation that related to the complaint.The cause for reoperation is unknown.This submission is 1 of 1 devices involved in this event.

Event Description

Email received through customer service on 28 december 2022 indicating that the regional manager wants just a single stalif c removal instrument shipped to him instead of the whole set; implying that a removal case has been scheduled.

• Brand Name: STALIF C CAGE 3 SCREW TAPERED
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• Manufacturer (Section D): CENTINEL SPINE, LLC; 900 airport road, suite 3b; west chester PA 19380
• Manufacturer (Section G): ELITE MEDICAL; 8415wolf lake drive; bartlette TN 38133
• Manufacturer Contact: erin ward ; 900 airport road; suite 3b; west chester, PA 19380 ; 4848878894
• MDR Report Key: 16233545
• MDR Text Key: 308006773
• Report Number: 3007494564-2023-00001
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/28/2022
• 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