MAUDE Adverse Event Report:; INSERT, 3D EX SZ 5LT 9MM

Catalog Number 391-09-705

Device Problem Unstable (1667)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Revision surgery - due to instability; the surgeon performed a poly exchang from 5/9 to 5/15, left.

• Type of Device: INSERT, 3D EX SZ 5LT 9MM
• MDR Report Key: 10614462
• MDR Text Key: 209420046
• Report Number: 1644408-2016-00357
• 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: 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 391-09-705
• Device Lot Number: 282G1904
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention