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

Model Number	11104055
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were received confirming the event.Patient activity at the time or prior to the event is unknown.The continuation of spinal instability adjacent to the initial construct was reported to be the reason for the construct extension.It is unknown if the patient complied with post-operative care instructions or sustained a fall/impact.The root cause of this reported event has not been determined.Review of labeling notes: warnings cautions and precautions product labeling indicates ".Potential risks identified with the use of this device system, which may require additional surgery, include: device component fracture, loss of fixation, non-union, fracture of the vertebra, neurological injury, and vascular or visceral injury." device not yet returned.
Event or Problem Description
A male patient (age unknown) received an extension of a construct previously implanted (date unknown) due to continued degeneration/instability on (b)(6) 2016.On (b)(6) 2016, a revision surgery was again performed after radiographs indicated a connector used to join the two segments had separated.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.; san diego CA 92121
• MDR Report Key: 6013258
• Report Number: 2031966-2016-00073
• Device Sequence Number: 13589387
• Product Code: NKB
• UDI-Device Identifier: 00887517596246
• UDI-Public: 00887517596246
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K132014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/09/2016

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: 11104055
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2015
• Initial Report FDA Received Date: 10/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1