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

Model Number 10055445

Device Problems Device Damaged by Another Device (2915); Material Deformation (2976)

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

Event Date 10/13/2022

Event Type  malfunction  

Manufacturer Narrative

The device was received by nuvasive and confirmed the complaint.Examination one of the locking cam sockets is damaged with the locking feature deformed/smashed and the cam still in place consistent with excessive torque applied and 360-degree rotation.The torque handle utilized in the case was returned and torque testing found it to be within require range.Review of the reported event and information received is consistent with other reports where the locking cam and or socket were damaged as a result of torque in excess of 40 in/lb and rotating the locking cam 360 degrees past the stop feature.The root cause is considered physical damage and the result of over torque and likely the result of hand tightening without a t-handle.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: "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." "correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant." "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 ensure that all components are ideally fixated prior to closure." "compatibility: all implants should be used only with the appropriately designated instrument (reference surgical technique)." "preoperative warnings: care should be used in the handling and storage of the implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.All non-sterile parts should be cleaned and sterilized before use.Devices should be inspected for damage prior to implantation.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." " packaging: packages for each of the components should be intact upon receipt.Devices should be carefully examined for completeness, and for lack of damage, prior to use.Damaged packages or products should not be used, and should be returned to nuvasive.The instruments and implants of the system may be supplied as either sterile or non-sterile.All implants provided non-sterile are single use and should be sterilized per instructions provided below.".

Event Description

On (b)(6) 2022 a patient was underwent a posterior fixation procedure.During the procedure when installing a cross connector one side fastened but when the surgeon tried to disengage it there was no resistance to the locking cam.The surgeon opted to not implant a cross connector as he was confident in the installed fixation without it.The surgery was completed with no issue or adverse patient consequences.

Event Description

No additional information.

Manufacturer Narrative

Upon further review of the event and reported malfunction, it was determined this event did not lead to death or serious injury and the malfunction is not likely to lead to death or serious injury if it were to recur.If additional, relevant information is received that alters this conclusion, a supplemental report will be submitted.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16474296
• MDR Text Key: 310957236
• Report Number: 2031966-2023-00037
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517534705
• UDI-Public: 887517534705
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143684
• 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
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10055445
• Device Lot Number: N332939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2022
• 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: T-HANDLE, 10000770, G142758
• Patient Sex: Prefer Not To Disclose