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

Model Number 13550000

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

Radiographs confirmed the reported event.There was no reported trauma, fall or accident that may have triggered the event.Inspection of the tulip thread start dimension shows that the dimensions meet established specifications.Visual inspection notes characteristics that are consistent with misalignment of the threaded components; subsequently threads were damaged in a manner that prevented complete locking of the construct.Three lock screws appear to have been provisionally tightened, but not locked to the specified torque value.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." "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 compressor) in the set, as the rod may not be able to normalize to the tulip.".

Event Description

On (b)(6) 2015, a (b)(6) year old male patient was implanted with a gsb global spinal balance system at l3-s1.Post-operative radiographs showed that the lock screws loosened at left l4 and l5, and right l3 and l5.The rod at left l3 appears to have slipped but the lock screw remained with the tulip.On (b)(6) 2015 a revision surgery was completed in which the screws were replaced.No patient injury was reported.

• Brand Name: GSB GLOBAL SPINAL BALANCE SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: stacy gregory ; 7475 lusk blvd; san diego, CA 92121 ; 8587360313
• MDR Report Key: 5368264
• MDR Text Key: 36058311
• Report Number: 2031966-2015-00093
• Device Sequence Number: 1
• Product Code: NKB
• 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

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
• Device Operator: No Information
• Device Model Number: 13550000
• Device Lot Number: JP8966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2015
• Initial Date FDA Received: 01/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2015
• 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
• Patient Age: 76 YR