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

Model Number 135550000

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation.Photographs of explant were reviewed; no thread damage was visible.Review of surgical notes revealed final tightening was performed through reducing instrumentation which has been associated with incomplete seating of components and suggests user technique contributed to the event.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." ".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 final-tighten through compression instruments in the set, as the rod may not be able to normalize to the tulip.".

Event Description

On (b)(6) 2016, a female patient received a discectomy with fusion in which a laterally-placed interbody with posterior fixation at l3-l5 without issue.(b)(6) 2017, follow-up radiographs revealed a loosened lock screw at left l3.The revision took place on (b)(6) 2017; the pedicle screw and lock screw at the left l3 position were replaced without issue.No patient injury has been reported.

• Brand Name: GSB GLOBAL SPINAL BALANCE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd; san diego, CA 92121 ; 8588825019
• MDR Report Key: 6334645
• MDR Text Key: 67828940
• Report Number: 2031966-2017-00007
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517551702
• UDI-Public: 00887517551702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 135550000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1