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

Model Number	16015540
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 as product remains in-situ.No radiographs or images were provided to confirm the alleged event.No additional investigation ca be conducted at this time.Labeling review: ".As with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications known to occur include: bending, fracture or loosening of implant component(s)." post-operative warnings ".During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.".
Event or Problem Description
On (b)(6) 2018, a patient underwent a vertebral body replacement at l1-l5 levels and a posterior spinal fusion at l3 level.On (b)(6) 2019, a screw back out was identified.A revision procedure is planned but has not been performed at this time.No patient injury has been reported.
Additional Manufacturer Narrative
Patient underwent a revision procedure on (b)(6) 2019, where construct was removed with no issues and replaced with unknown product from t11-s1.Patient has been reported in good condition.
Event or Problem Description
For updated information.

• 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: 8448621
• Report Number: 2031966-2019-00172
• Device Sequence Number: 14184566
• Product Code: NKB
• UDI-Device Identifier: 00887517553218
• UDI-Public: 887517553218
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K132014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2019

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: 16015540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1