MAUDE Adverse Event Report: EQUINOXE; EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM

Catalog Number 320-20-34

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 12/26/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Index surgery: (b)(6) 2018.Revision due to infection.The case report form indicates this event is possibly related to devices and definitely related to procedure.

Manufacturer Narrative

Engineering evaluation noted that the revision reported was likely the result of infection, which is included in the product labeling under general surgical risks.

Manufacturer Narrative

Section h10: the following sections have additional info : (d4) catalog number.

• Brand Name: EQUINOXE
• Type of Device: EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM
• MDR Report Key: 8331476
• MDR Text Key: 135883730
• Report Number: 1038671-2019-00071
• 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,Followup
• Report Date: 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 320-20-34
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 127