MAUDE Adverse Event Report: EXACTECH, INC. EQUINOXE; GLENOID

Catalog Number 9999

Device Problems Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)

Patient Problem Pain (1994)

Event Date 12/05/2018

Event Type  Injury  

Manufacturer Narrative

This event report was received through clinical data collection activities.Pending evaluation.

Event Description

Index surgery: (b)(6) 2015.Patient has increased pain; x-ray reveals poly sheared off of ingrown cage.The case report form indicates this event is definitely related to devices and definitely related to procedure.

Manufacturer Narrative

This to determined to be a duplicate of a different submission.Filed in error.

• Brand Name: EQUINOXE
• Type of Device: GLENOID
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• MDR Report Key: 8178484
• MDR Text Key: 130782137
• Report Number: 1038671-2018-00953
• Device Sequence Number: 1
• Product Code: KWT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Weight: 69