MAUDE Adverse Event Report: NUVASIVE INC NUVASIVE PRECEPT SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 8827540006

Device Problem Failure to Disconnect (2541)

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

Event Date 06/30/2023

Event Type  malfunction  

Manufacturer Narrative

The devices were not returned to nuvasive although provided photographs confirmed the complaint.Review of the provided photographs identified the reduction screw tabs have been removed and minor damage to the internal threads of the tulip was identified.Additionally only one side of the tulip was engaged by the slip-on guide and the un-attached tulip feature is wedged between the guide blades.The root cause of the reported failed disengagement could not be definitely determined although physical damage to the screw during reduction tab removal and or incomplete attachment of the guide creating splay hindering blade retraction as the likely cause or contributors to the event.Should the device be returned and more information be provided an additional report will be filed.Labeling review: "potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery." "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.Care should be taken to insure that all components are ideally fixated prior to closure." "compatibility¿ all implants should be used only with the appropriately designated instrument (reference surgical technique)."pre-operative warnings.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "method of use please refer to the surgical technique for this device." h3 other text : device not returned.

Event Description

During a spinal procedure the slip-on guide did not disengage from the pedicle screw.The pedicle screw was removed and replaced with a new one.No patient injury or consequences were reported.

Event Description

New and updated information listed in section h10.

Manufacturer Narrative

The devices were returned to nuvasive and not confirmed as won't disengage but rather jammed due to malalignment.Examination of the returned devices identified only one side of the tulip was engaged by the slip-on guide and the un-attached side of the tulip feature is wedged between the guide blades splaying the guide.A removal tool was utilized and the guide was easily removed form the tulip noting minor contact damage to the tulip and the guide blades are now splayed.The root cause of the reported failed disengagement appears to be the result of misalignment during guide attachment and difficulties with removal tool utilization.No removal tool was identified or returned for evaluation.No additional investigation can be completed.Manufacturing review: review of the device history records of all devices notes no material non-conformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: "potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery." "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.Care should be taken to insure that all components are ideally fixated prior to closure." "compatibility¿ all implants should be used only with the appropriately designated instrument (reference surgical technique)."pre-operative warnings.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." "method of use please refer to the surgical technique for this device." new or corrected information found on sections:.

Manufacturer Narrative

Correction: g3, correct date sep 27, 2023.

Event Description

Corrected information listed on h10.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 17397957
• MDR Text Key: 319852452
• Report Number: 2031966-2023-00149
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517103482
• UDI-Public: 887517103482
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K171894
• 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,Followup,Followup
• Report Date: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8827540006
• Device Lot Number: JP14212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2017
• 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: (B)(6).
• Patient Sex: Prefer Not To Disclose