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

Model Number 520621

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

Patient Problem Insufficient Information (4580)

Event Date 06/14/2022

Event Type  Injury  

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 Description

Patient hospitalized for removal of disassembled rod couplers.

• 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: 15028932
• MDR Text Key: 295987990
• Report Number: 3011390763-2022-00003
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: B6785206210
• UDI-Public: B6785206210
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/15/2022
• 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
• Patient Age: 75 YR
• Patient Sex: Female