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

Model Number 11355120

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

Radiographs were received confirming that the rod became disengaged from the screw.A pre-bent lordotic rod was implanted; it was reported during the procedure that the rod bend inadvertently shifted and the bend axis was oriented in the coronal plane instead of the sagittal plane.The rod was left in this orientation.It is not known if this contributed to the event.Additionally, the construct spanned three spine levels; polyaxial screws were implanted in the cranial and caudal-most vertebral bodies only.A revision procedure was completed on (b)(6) 2015.Witness marks on the explants suggest lock screws may not have made contact with the rod.Root cause has not been determined.Evaluation is in process.Review of labeling notes: "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, neurological, vascular or visceral injury.".

Event Description

On (b)(6) 2015 patient was implanted with a (b)(6) spinal balance system at l1-l4.Approximately two weeks postoperatively, patient complained of back pain.Ct and mri showed that the rod had become disengaged from the left l4 screw but the lock screw remained inside the tulip.On (b)(6) 2015 a revision surgery was completed in which the left l4 screw and rod 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; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: stacy gregory ; 7475 lusk blvd; san diego, CA 92121 ; 8587360313
• MDR Report Key: 5287674
• MDR Text Key: 33232792
• Report Number: 2031966-2015-00081
• 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: Physician
• Device Model Number: 11355120
• Device Lot Number: CT34858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2015
• 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