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

Model Number	8439560
Medical Device Problem Codes	Mechanical Problem (1384); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	02/19/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned, but radiograph confirmed the separation.The device remains in-situ and no further investigation can be completed at this time.It is unknown if the patient complied with post-operative instructions or sustained an impact.Root cause has not been determined, no conclusion can be drawn.Review of labeling notes: warnings and cautions and precautions "potential risks identified with the use of this device system, which may require additional surgery include: device component fracture.Internal fixation appliances are load sharing devices that hold bony structures in alignment until healing occurs."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." "contraindications include but are not limited to: infection, local to the operative site.Signs of local inflammation.Patients with known sensitivity to the materials implanted.Patients who are unwilling to restrict activities or follow medical advice.Patients with inadequate bone stock or quality." device remains in-situ.
Event or Problem Description
On (b)(6) 2015 a (b)(6) male patient underwent a procedure that included four intervertebral spacers and six level posterior fixation.Three months after surgery the patient was experiencing some pain (radiculopathy) down right side.Radiographic images showed a component separation at s1.The surgeon has elected to monitor the patient.No revision surgery is scheduled at this time.

• 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: 5493318
• Report Number: 2031966-2016-00017
• Device Sequence Number: 300203
• Product Code: NKB
• UDI-Device Identifier: 00887517252654
• UDI-Public: 00887517252654
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K092287
• 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): 03/08/2016

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: No Information
• Device Model Number: 8439560
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2016
• Initial Report FDA Received Date: 03/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR