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

Model Number	15455500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were not returned to confirm the event.The explanted hardware did not return for evaluation.The root cause cannot be determined and no further investigation can be completed at this time.Labeling review: "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, metal sensitivity or allergic reaction to a foreign body, infection.".
Event or Problem Description
On (b)(6) 2016, a (b)(6) year-old male patient underwent posterior spinal fusion at the t10-s2 levels.The rod reportedly fractured on both sides at the l4/5 level.On (b)(6) 2017 revision surgery occurred to replace the fractured rod.No patient injury was 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: 6615991
• Report Number: 2031966-2017-00060
• Device Sequence Number: 788754
• Product Code: NKB
• UDI-Device Identifier: 00887517594204
• UDI-Public: 00887517594204
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K132014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/06/2017

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: 15455500
• Device Lot Number: CT52350
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2017
• Initial Report FDA Received Date: 06/06/2017
• 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