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

Model Number 520233

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vertebral Fracture (4520)

Event Date 12/27/2023

Event Type  Injury  

Manufacturer Narrative

Original surgery when the devices were implanted: (b)(6) 2023 devices explanted: (b)(6) 2023; devices not available and not returned for investigation.Further additional information reported from complainant: " a 66 year old obese female who had a grade 1 spondylolisthesis.She underwent a laminectomy and presson psf without interbody.Pod #1 xrays showed good reduction, on pod#3 she developed increasing leg pain, and on pod#6 she was readmitted.Mri shows large l4-l5 disc herniation with severe central stenosis and loss of reduction.Ct scan shows no fracture, and ideal screw trajectory." case review and surgeon interview conducted by company representative on 12/28/2023: a revision surgery was performed by the surgeon yesterday afternoon, 6 days after the primary surgery, on a 66 y/o female with a bmi of 38.She had developed post-op neurological symptoms.The surgeon discovered intra-operatively that an l5 pedicle was fractured and that there was a large central disc herniation.Also, the presson hardware had not failed and was fully intact.He removed the presson rods so as introduce an interbody device.He also replaced the one pedicle screw in the fractured pedicle with a larger diameter presson screw, going up to a 8.5mm.He then added new presson rods.The old rods will not be returned.The surgeon and his pa expressed increased confidence in presson and a new appreciation for the need to use interbody devices.Device review 1.The explanted devices were not returned to allow for further evaluation.2.The part numbers and lot numbers of the devices used in the case were identified based on the surgery information from the case records provided by the customer service, and are as follows: system part description part no.Udi-di no.Lot no.Qty presson mis pedicle screw 7.5 x 45mm cannulated 520233 (b)(4).M96585 3 presson mis pedicle screw 7.5 x 40mm cannulated 520232 (b)(4).J84871 1 presson fixed length coupler 20mm 520282 (b)(4).G86140 1 presson fixed length coupler 18mm 520281 (b)(4) g87677 1 presson locking rivets 520864 (b)(4) dhr review summary - 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 and replacement of pedicle screw.

• 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): P&F MACHINING; 8450 quaday ave. ne; otsego 55330
• MDR Report Key: 18536690
• MDR Text Key: 333156029
• Report Number: 3011390763-2024-00001
• Device Sequence Number: 1
• Product Code: MNI
• UDI-Device Identifier: B6785202330
• UDI-Public: B6785202330
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 133287
• 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: 01/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 520233
• Device Catalogue Number: 520233
• Device Lot Number: M96585
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2023
• 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 Age: 66 YR
• Patient Sex: Female