MAUDE Adverse Event Report: EXTREMITY MEDICAL, LLC. AXIS; BONE SCREW

Catalog Number 130-65145

Device Problems Device Dislodged or Dislocated (2923); Appropriate Term/Code Not Available (3191)

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

Event Date 04/18/2020

Event Type  malfunction  

Event Description

It was reported that a 6.5mm x 145mm beam was removed in (b)(6) from the 1st ray because it was backing out.It was replaced with a 6.5mm x 150mm beam.A 4.5mm x 140mm beam remains in the patient which appeared on x-ray to be well-fixed and is supporting the onset of bony fusion through the lateral column.

• Brand Name: AXIS
• Type of Device: BONE SCREW
• Manufacturer (Section D): EXTREMITY MEDICAL, LLC.; 300 interpace parkway; suite 410; parsippany, nj
• Manufacturer Contact: brian smekal ; 300 interpace parkway; suite 410; parsippany, nj ; 5888980898
• MDR Report Key: 10078613
• MDR Text Key: 192048458
• Report Number: 3007289093-2020-00010
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K171018
• 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: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 130-65145
• Date Manufacturer Received: 04/21/2020
• 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