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 event when an employee heard a sales representative mention an incore removal.During follow-up communication with the sales representative, it was reported that the patient had a diagnosed vitamin d deficiency prior to implantation with the incore lapidus system.The vitamin d deficiency was not address prior to implantation with the incore lapidus system.The surgeon attributes the screw breakages with this circumstance.There is no alleged or detected deficiency with the device.

Event Description

The incore lapidus system was implanted in a patient.After implantation, both screws broke.The incore lapidus system was removed.The proximal pieces of the screws were removed from the patient.The surgeon determined to leave the post and distal ends of the screws implanted.The process in the surgical technique was not attempted.Two additional bone screws were implanted.There are no reported patient complications.

• 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 ; 5743762064
• MDR Report Key: 9268980
• MDR Text Key: 164855286
• Report Number: 3009540749-2019-00012
• 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
• Date Manufacturer Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention