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

Model Number	10055440
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is currently in progress.A review of the device history record was performed and no discrepancies were found.Upon completion of the investigation or if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.
Event or Problem Description
It was reported that during a posterior fixation procedure, the surgeon attempted to unlock and remove the cross-connector from the fixation rods; however, the locking cams on both sides of the cross-connector could not be unlocked.Therefore, the surgeon had to remove the rods and replace with new rods and a new cross-connector.It was additionally reported that the surgeon encountered problems with tightening the cross-connector's center screw with a torque handle.There was no further procedure impact reported and no adverse patient impact was reported in association with this event.No additional information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The reported event was confirmed by review of photographs of the damaged device, showing over-rotation of the lock mechanism and heavy damage to the hex drive feature.The torque handle used was returned to the distributor, who provided the torque inspection report showing the handle to be within specification.No device was returned to nuvasive qa for evaluation; further, operative notes were not provided for review of usage/technique.A review of device manufacturing records was performed and no discrepancies relevant to the reported event were found.A definitive root cause was unable to be determined with the information provided; however, it is likely the event resulted from an unintended use error by excessive force and over-rotation applied by the user.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." ".All lock screws should be final-tightened with the counter-torque and torque t-handle.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." ".All implants should be used only with the appropriately designated instrument (reference surgical technique)" ".Pre-operative warnings: care should be used in the handling and storage of the reline implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." if any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: 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: geoffrey gannon ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 16989410
• Report Number: 2031966-2023-00116
• Device Sequence Number: 15192845
• Product Code: NKB
• UDI-Device Identifier: 00887517534699
• UDI-Public: 887517534699
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10055440
• Device Lot Number: N340818
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 05/23/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: RELINE-O TI RODS; RELINE-O X-LINK TORQUE HANDLE
• Patient Sex: Prefer Not To Disclose