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

Model Number	520629
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/21/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The radiographs provided confirm the reported event, that the construct was not assembled.The rod (p/n 520629, lot 055877) located on the cranial left side was observed under fluoroscopy as being disassociated from the coupler.The root cause was that the construct exceeded the polyaxial limit.The explanted devices were not returned to allow for further evaluation.Dhr review - no material non-conformance's, 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.
Event or Problem Description
Patient hospitalized for removal and replacement of disassembled rod and coupler.

• Brand Name: PRESSON
• Common Device Name: 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
• MDR Report Key: 20260036
• Report Number: 3011390763-2024-00002
• Device Sequence Number: 15448623
• Product Code: MNI
• UDI-Device Identifier: B6785206290
• UDI-Public: B6785206290
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K223529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2024
• Device Model Number: 520629
• Device Catalogue Number: 520629
• Device Lot Number: 055877
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/21/2024
• Initial Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/23/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male