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

Model Number	520632
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient hospitalized for removal of disassembled end coupler and telescoping rod.
Additional 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
• 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
• Manufacturer Contact: jared crocker ; 2825 e cottonwood pkwy ste 330; salt lake city, UT 84121 ; 8017028592
• MDR Report Key: 16473265
• Report Number: 3011390763-2023-00001
• Device Sequence Number: 17438792
• Product Code: MNI
• UDI-Device Identifier: B6785206320
• UDI-Public: B6785206320
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: 160820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female