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

Model Number	13550000
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was received as the devices remained in-situ and no radiographs could be provided confirming the alleged screw loosening.The patient was reported to have followed post op activity instructions and had not experienced any falls or other accidents.It is unknown whether the loosened lock screws were replaced or retightened during the revision procedure.While a root cause for the issue could not be confirmed review of the information provided would suggest incomplete final torque down or rod interference during lock screw placement.No additional investigation can be completed.Label review: "potential adverse events and complications - as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries." "potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s), loss of fixation." "all lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments." "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." device not returned.
Event or Problem Description
On unknown date a patient underwent a posterior fixation procedure on unknown levels of the spine.On a unknown date it was discovered during a routine follow up two of the connectors lock screws had loosened.On a unknown date a revision occurred to address the loosened screws.It is unknown what occurred during that revision.The patient was reported to have recovered well post revision.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; 92121 CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 13013919
• Report Number: 2031966-2021-00189
• Device Sequence Number: 4952349
• Product Code: NKB
• UDI-Device Identifier: 00887517551702
• UDI-Public: 887517551702
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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: 13550000
• 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: 11/16/2021
• Initial Report FDA Received Date: 12/15/2021
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown