MAUDE Adverse Event Report: MICROPORT ORTHOPEDICS EVOLUTION® REV PASS THRU SCREW

Model Number ESS00001

Device Problem Insufficient Information (3190)

Patient Problem Unspecified Infection (1930)

Event Date 09/27/2019

Event Type  Injury  

Manufacturer Narrative

This event will be updated when investigation is complete.

Event Description

Allegedly, patient was revised due to infection.

Manufacturer Narrative

Updated explant and implant dates.

• Brand Name: EVOLUTION® REV PASS THRU SCREW
• Type of Device: SCREW
• Manufacturer (Section D): MICROPORT ORTHOPEDICS; 5677 airline rd; rachael wise; arlington TN 38002
• MDR Report Key: 9227068
• MDR Text Key: 163608824
• Report Number: 3010536692-2019-01117
• Device Sequence Number: 1
• Product Code: HRY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: ESS00001
• Device Lot Number: 1683415
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/03/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention