MAUDE Adverse Event Report: NUVASIVE, INCORPORATED GBS GLOBAL SPINAL BALANCE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	16017550
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.A radiograph was provided and alleged event was confirmed.No root cause can be confirmed at this time.Labeling review: "potential adverse events and complications: 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." "warnings, cautions and precautions: if healing is delayed, or does not occur, the implant may eventually loosen, bend, or break." "patient education:the patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen." "post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration.".
Event or Problem Description
On (b)(6) 2019 a patient underwent an extreme lateral interbody fusion procedure at l2-3 and l4-5 using coroent xl.On (b)(6) 2019 the secondary procedure, a posterior fixation, was performed.On (b)(6) 2020 a revision procedure was performed due to a pedicle screw loosening at l2 due to local kyphosis.The pedicle screw was replaced by a new one.

• Brand Name: GBS GLOBAL SPINAL BALANCE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 9960716
• Report Number: 2031966-2020-00078
• Device Sequence Number: 2827659
• Product Code: NKB
• UDI-Device Identifier: 00887517553959
• UDI-Public: 887517553959
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2020

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: 16017550
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR