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

Catalog Number 9999

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

Pending evaluation.

Event Description

Revision ¿ reason not reported.

• Brand Name: EQUINOXE
• Type of Device: EQUINOXE STEM
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66th court; gainesville FL 32653
• Manufacturer Contact: graham cuthbert ; 2320 nw 66th court; gainesville, FL 32653 ; 3523771140
• MDR Report Key: 8147798
• MDR Text Key: 129820235
• Report Number: 1038671-2018-00940
• Device Sequence Number: 1
• Product Code: KWT
• 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: Other
• Type of Report: Initial
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 9999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/03/2018
• 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