MAUDE Adverse Event Report: NEXUS SPINE, LLC PRESSON; PEDICLE SCREW

Model Number 520225

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2020

Event Type  Injury  

Manufacturer Narrative

Evaluation summary: pedicle screw disassembled.The pedicle screw removed showed damage possibly due to a bone removal instrument.Other remarks: complaint follow-up from remediation activities resulting in late filing.

Event Description

Patient hospitalized for removal and replacement of disassembled pedicle screw.

• Brand Name: PRESSON
• Type of Device: PEDICLE SCREW
• Manufacturer (Section D): NEXUS SPINE, LLC; 2825 e cottonwood pkwy ste 330; salt lake city UT 84121
• MDR Report Key: 17725914
• MDR Text Key: 323146342
• Report Number: 3011390763-2022-00001
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• PMA/PMN Number: 160820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2022

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: Health Professional
• Device Model Number: 520225
• Device Catalogue Number: 5220225
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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