MAUDE Adverse Event Report: NUVASIVE GSB GLOBAL SPINAL BALANCE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	16017580
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.Radiographs provided confirmed the alleged event.It is unknown if patient followed post-operative activity restrictions.Labeling review: contraindications "contraindications include but are not limited to: infection, local to the operative site.Signs of local inflammation.Patients with known sensitivity to the materials implanted.Patients who are unwilling to restrict activities or follow medical advice.Patients with inadequate bone stock or quality." potential adverse events and complications ".Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening or implant components(s)." no product return.
Event or Problem Description
On (b)(6) 2018, a patient underwent a posterior spinal fusion at the th5-iliac levels.On (b)(6) 2019, a lock screw back out was identified.Patient underwent a revision procedure on (b)(6) 2019, where the set screw was replaced with no reported issues.Not patient injury reported.

• Brand Name: GSB GLOBAL SPINAL BALANCE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 8443984
• Report Number: 2031966-2019-00171
• Device Sequence Number: 278000
• Product Code: NKB
• UDI-Device Identifier: 00887517554017
• UDI-Public: 887517554017
• 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: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2019

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: 16017580
• 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: 02/27/2019
• Initial Report FDA Received Date: 03/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR