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

Model Number	520621
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	06/14/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The radiographs provided confirm the reported event.On the left side, the 22mm hybrid coupler [p/n 520611, lot h064698] pulled apart from the devices cranial and caudal to it.On the right side, the 18mm hybrid coupler [p/n 520609, lot 061295] stayed joined to the 28mm tele rod [p/n 520621, lot 060783] but the two pulled apart from the devices cranial and caudal to them.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.
Event or Problem Description
Patient hospitalized for removal of disassembled rod couplers.

• 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: 15028932
• Report Number: 3011390763-2022-00003
• Device Sequence Number: 4763162
• Product Code: MNI
• UDI-Device Identifier: B6785206210
• UDI-Public: B6785206210
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: 160820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 07/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: 520621
• Device Catalogue Number: 5220621
• Device Lot Number: 060783
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/14/2022
• Initial Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 Age: 75 YR
• Patient Sex: Female