MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS INCORE LAPIDUS SYSTEM; BONE SCREW

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Nextremity solutions became aware of this complaint when an employee heard a sales representative mention an incore removal.During follow-up communication with the sales representative, it was reported that the surgeon inadvertently implanted the incore lapidus system in such a way that it was not implanted in the cuneiform.This is the source of the removal.It was also reported that the post plug screw was severly over tightened in the original procedure, making it difficult to remove with the driver during the removal.There is no alleged or detected deficiency with the device.

Event Description

A patient was implanted with the incore lapidus system.After implantation at a later date, the incore lapidus system was removed by patient request.The screws were removed per the surgical technique.The surgeon was unable to remove the post plug screw from the post with the driver, and so removed the post and post plug screw with an alternative method.There were no patient complications reported after the removal.

• Brand Name: INCORE LAPIDUS SYSTEM
• Type of Device: BONE SCREW
• Manufacturer (Section D): NEXTREMITY SOLUTIONS; 210 north buffalo street; warsaw IN 46580
• Manufacturer (Section G): NEXTREMITY SOLUTIONS; 210 north buffalo street; warsaw IN 46580
• Manufacturer Contact: chris cook ; 210 north buffalo street; warsaw, IN 46580 ; 5743672064
• MDR Report Key: 9268799
• MDR Text Key: 164854149
• Report Number: 3009540749-2019-00011
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180257
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention