MAUDE Adverse Event Report:; INSERT, 3D EX SZ 4LT 11MM

Catalog Number 391-11-704

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

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 poly was swapped out for a thicker poly.

• Type of Device: INSERT, 3D EX SZ 4LT 11MM
• MDR Report Key: 10601066
• MDR Text Key: 209147671
• Report Number: 1644408-2016-00343
• 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: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 391-11-704
• Device Lot Number: 59603997
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention