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

Catalog Number 144-10031

Device Problem Loss of or Failure to Bond (1068)

Patient Problem Non-union Bone Fracture (2369)

Event Date 09/08/2020

Event Type  Injury  

Event Description

Omni mtp plate removed due to non-union.

• 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: 10665278
• MDR Text Key: 211030534
• Report Number: 3007289093-2020-00021
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 144-10031
• Date Manufacturer Received: 09/23/2020
• 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