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

Model Number	16027540
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was unable to be confirmed due to limited information received from the customer.No device was returned to nuvasive for evaluation; further, operative notes and/or radiograph images were not provided for review of usage/technique.A definitive root cause was unable to be determined with the information provided.Labeling review: "warnings, cautions and precautions: the safety and effectiveness of these devices for any other conditions are unknown.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 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" "inspect the implant and packaging for signs of damage, including scratched or damaged devices or damage to the sterile barrier.Do not use the reline implants if there is any evidence of damage" "the silencer and gator reducers are not compatible with reduction screws or reduction uni-planar screws and may damage the implant if used.Only the matador reducer and rocker may be used" "compatibility: do not use the reline system with components of other systems, other than the armada system.Refer to the armada system instructions for use for a list of the armada system indications for use.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system" 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 the patient underwent an initial posterior fixation procedure utilizing percutaneous pedicle screws.During the procedure, following implantation of the pedicle screw, the locking screw was unable to be delivered into the reduction screw tulip.Several lock screws were attempted and none were able to fit.The procedure was converted to an open approach to complete the fixation.No patient harm or further patient impact was reported.

• Brand Name: NUVASIVE RELINE MAS REDUCTION SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 14743962
• Report Number: 2031966-2022-00114
• Device Sequence Number: 5175233
• Product Code: NKB
• UDI-Device Identifier: 00887517556981
• UDI-Public: 887517556981
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 16027540
• Device Catalogue Number: N/A
• 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: 05/24/2022
• Initial Report FDA Received Date: 06/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: UNK LOCK SCREW
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female