MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 13550000

Device Problem Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2022

Event Type  malfunction  

Manufacturer Narrative

No device has been returned for evaluation but radiographs provided confirmed the complaint.Review of the provided radiographs and reported event identify nuvasive's devices were combined with another manufacturer's devices which is considered an off-label usage as results are untested and may vary.Review of the reported event suggests incomplete lock screw final tightening and or incompatible rod size as likely cause or contributor.No additional investigation can be completed at this time.Labeling review: ".Potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant components." ".Warnings, cautions and precautions: the implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.Benefit of spinal fusions utilizing any pedicle screw fixation system has not been adequately established in patients with stable spines.Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments e.G.C/d rack and figure 8 compressor in the set, as the rod may not be able to normalize to the tulip.Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw.The bulleted portion of the nose of the rod and the faceted portion of the rod where the inserter locks down on the rod must extend fully outside of the most inferior or most superior tulip on the construct.The set screw cannot be locked down on this unusable portion of the rod, as this may compromise the stability of the construct.Cross connectors are designed specific to the rod diameter and cannot be used on the tapered section of tapered rods.If using cross connectors on tapered rods, only attach them on constant diameter rod sections.Care should be taken to insure that all components are ideally fixated prior to closure." ".Compatibility: unless stated otherwise, nuvasive devices are not to be combined with the components of another system.All implants should be used only with the appropriately designated instrument." ".Pre-operative warnings: care should be used during surgical procedures to prevent damage to the devices and injury to the patient.".

Event Description

On the (b)(6) 2022 a patient required a second revision due to other manufacturer's 5.5 rod separation at iliac.Imaging showed the lock screw was still engaged to the iliac screw tulip.Surgeon noted lock screw was sitting flush in the tulip head.Lock screw was replaced, an additional iliac screw was placed on the same side (l) utilizing a 30mm offset connector, replaced other manufacturer's rod with a nuvasive 5.5mm cocr rod and bent the rod over hang to create a ¿hook¿ to stop another slip.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 14982684
• MDR Text Key: 304545238
• Report Number: 2031966-2022-00122
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517551702
• UDI-Public: 887517551702
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K182974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13550000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/21/2022
• 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
• Treatment: OTHER MANUFACTURER'S ROD
• Patient Sex: Prefer Not To Disclose