MAUDE Adverse Event Report: NUVASIVE, INC. GSB GLOBAL SPINAL BALANCE SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	11111550
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/18/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation as it remains in-situ.No revision has been completed at this time.It is unknown if the patient followed post-operative instruction.Radiographs confirmed the event.Root cause has not been determined and no conclusion can be drawn at this time; similar events have been associated with incomplete seating of components.Review of labeling notes: ".Warning cautions and precautions 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, nonunion or delayed union, fracture of the vertebra." ".Care should be taken to insure that all components are ideally fixated prior to closure." ".Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.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 even though restrictions in activity are followed." ".All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments (e.G.C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip.Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw.The bulleted portion of the nose of the rod and the faceted portion of the rod (where the inserter locks down on the rod) must extend fully outside of the most inferior or most superior tulip on the construct.The set screw cannot be locked down on this unusable portion of the rod, as this may compromise the stability of the construct.All set screws should be final-tightened with the counter- torque and torque t-handle.Do not able to normalize to the tulip.Cross connectors are designed specific to the rod on constant diameter rod sections.All set screws should be final-tightened with the counter- torque and torque t-handle.Do not final-tighten through compression instruments in the set, as the rod may not be able to normalize to the tulip." ".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." the device has not been returned.
Event or Problem Description
On (b)(6) 2015 a (b)(6) year-old female underwent a posterior spinal fusion from t10-s1.Radiographs obtained (b)(6) 2016 showed 4 sets screws appear disengaged.Revision scheduled.No patient injury has been reported.

• Brand Name: GSB GLOBAL SPINAL BALANCE SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6269012
• Report Number: 2031966-2016-00096
• Device Sequence Number: 11132172
• Product Code: NKB
• UDI-Device Identifier: 00887517227560
• UDI-Public: 00887517227560
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K132014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2016

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: Physician
• Device Model Number: 11111550
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR