MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE SPHERX II PEDICLE SCREW SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	8856545
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/15/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's surgery date cannot be confirmed at this time.The implants were not returned and no radiographs were provided to confirm the event.No further investigation can be completed at this time.It is unknown if the patient complied with post-operative instructions.Root cause has not been determined, no conclusion can be drawn.Review of the device history records for the interbody devices notes no material nonconformances, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions related to the interbody implants.Nuvasive implants met acceptance criteria upon release.Review of labeling notes: warning and cautions and precautions "potential risks identified with the use of this device system, which may require additional surgery include: device component fracture, bending or loosening of implant, loss of fixation, fracture of the vertebra and visceral injury.If healing is delayed, or does not occur, the implant may eventually loosen, bend or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant." device remains with patient.
Event or Problem Description
Nuvasive received (b)(4) indicating that in 2012 or 2013 a male had a pedicle screw system placed at l4-l5.In 2015 a scan confirmed that the lower right pedicle screw had fractured.Revision surgery took place in 2015, new screws and hardware were installed.More specific information is not known.

• Brand Name: NUVASIVE SPHERX II PEDICLE SCREW 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: 5567527
• Report Number: 2031966-2016-00028
• Device Sequence Number: 10868754
• Product Code: NKB
• UDI-Device Identifier: 00887517382023
• UDI-Public: 00887517382023
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K092287
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/11/2016

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: 8856545
• Device Lot Number: AS0190
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2016
• Initial Report FDA Received Date: 04/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1