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

Model Number	13015540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were not received for review.The implant remains in-situ, and no further investigation can be completed at this time.Root cause has not been determined, no conclusion can be drawn.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 and neurological, vascular or visceral injury." "loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant." device remains in-situ.
Event or Problem Description
On (b)(6) 2015, a (b)(6) female patient received an implant posteriorly at l4 - s1 with no interbodies used.Approximately two months postoperatively, radiographs showed that the left s1 screw shank fractured halfway down the screw shank itself.Device remains in-situ.No revision surgery is scheduled at this time.

• 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: 5480814
• Report Number: 2031966-2016-00012
• Device Sequence Number: 13528067
• Product Code: NKB
• UDI-Device Identifier: 00887517536846
• UDI-Public: 00887517536846
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 02/26/2016

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: 13015540
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2016
• Initial Report FDA Received Date: 03/04/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR