MAUDE Adverse Event Report: EXTREMITY MEDICAL, LLC. OMNI; BONE PLATE

Catalog Number 144-80011

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

Event Date 04/28/2021

Event Type  Injury  

Event Description

Union was achieved but patient had discomfort from the implant.

• Brand Name: OMNI
• Type of Device: BONE PLATE
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC.; 300 interpace parkway; suite 410; parsippany NJ 07054
• Manufacturer Contact: brian smekal ; 300 interpace parkway; suite 410; parsippany, NJ 07054 ; 9735888980
• MDR Report Key: 11991885
• MDR Text Key: 255962080
• Report Number: 3007289093-2021-00007
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180808
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2021

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: No Information
• Device Catalogue Number: 144-80011
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention