MAUDE Adverse Event Report:; INSERT, 3D EX SZ 7RT 9MM

Catalog Number 392-09-707

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

Corrected data: original initial report was submitted as follow up in error.

Event Description

Revision surgery - due to the patient having an infection.

• Type of Device: INSERT, 3D EX SZ 7RT 9MM
• MDR Report Key: 10708166
• MDR Text Key: 212255343
• Report Number: 1644408-2016-00626
• Device Sequence Number: 1
• Product Code: OIY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 10/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 392-09-707
• Device Lot Number: 329G1058
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention