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

Model Number 520632

Device Problems Detachment of Device or Device Component (2907); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 02/03/2023

Event Type  Injury  

Event Description

Patient hospitalized for removal of disassembled end coupler and telescoping rod.

Manufacturer Narrative

The radiographs provided confirm the reported event, that the construct was not assembled.The end coupler (p/n 520147, lot g86337) located on the cranial left side was observed under fluoroscopy as having disassociated from the telescoping rod (p/n 520632, lot 59176).The explanted devices were not returned to allow for further evaluation; therefore, a root cause cannot be determined.Dhr review - no material non-conformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to the event.Parts met acceptance criteria upon release.The product related deviation did not introduce, add or contribute to additional product risk.

• Brand Name: PRESSON
• Type of Device: PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NEXUS SPINE, LLC; 2825 e cottonwood pkwy ste 330; salt lake city UT 84121
• Manufacturer (Section G): PRECISION MEDICAL TECHNOLOGIES; 2059 n. pound drive west; warsaw IN 46582
• Manufacturer Contact: jared crocker ; 2825 e cottonwood pkwy ste 330; salt lake city, UT 84121 ; 8017028592
• MDR Report Key: 16473265
• MDR Text Key: 310589178
• Report Number: 3011390763-2023-00001
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: B6785206320
• UDI-Public: B6785206320
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 160820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/02/2023

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: 520632
• Device Catalogue Number: 520632
• Device Lot Number: 59176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female