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

Model Number	16016545
Medical Device Problem Codes	Loosening of Implant Not Related to Bone-Ingrowth (4002); Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation nor were radiographic images provided to confirm the alleged event.No bone quality test results provided.At this time alleged event could not be confirmed.Insufficient information provided to determine the root cause.Labeling review: ".Contraindications include but are not limited to: patients who are unwilling to restrict activities or follow medical advice, patients with inadequate bone stock or quality.".".Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration as well as to other 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.".
Event or Problem Description
On (b)(6) 2018, patient with a fractured l1 underwent a posterior lumbar interbody fusion at l2/l3 levels with posterior fixation from t10-l3.A loose screw at l3 and a cage back out was identified post-operative.On (b)(6) 2018 a revision procedure was performed to replace the l3 level screw and the cage.Construct was also extended from t10 to s2 and a cross connector was added.No patient injury reported.

• Brand Name: GSB GLOBAL SPINAL BALANCE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7924634
• Report Number: 2031966-2018-00146
• Device Sequence Number: 19238662
• Product Code: NKB
• UDI-Device Identifier: 00887517553584
• UDI-Public: 887517553584
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2018

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: 16016545
• 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: 08/29/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1