MAUDE Adverse Event Report: NUVASIVE, INC. SPHERX II - MAS DEFORMITY SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number 7070000

Device Problems Mechanical Problem (1384); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

On (b)(6) 2014 patient underwent plif fusion surgery involving a peek interbody spacer and posterior fixation from l3-s1.It was reported that the patient had fallen on multiple occasions.During routine follow up, the surgeon identified that the pedicle bone screw head reportedly disassociated from the shank.No patient injury was reported.Surgeon elected to continue to monitor patient; no revision is planned.

Manufacturer Narrative

(b)(4).No radiographs nor product information was provided.No product was returned and no further evaluation of the product can be complete at this time.Patient activity at the time or prior to the event is unknown.Patient's bone quality is unknown.The degree of spinal instability is unknown.It is unknown if the patient failed to comply with post-operative care instructions.The root cause of the issue remains unknown; however, the patient's history suggests the event may be related to the impacts sustained.

• Brand Name: SPHERX II - MAS DEFORMITY SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd.; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd; san diego, CA 92121 ; 8588825019
• MDR Report Key: 4906471
• MDR Text Key: 6536595
• Report Number: 2031966-2015-00038
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K102514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 07/06/2015

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
• Device Operator: Health Professional
• Device Model Number: 7070000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2015
• Initial Date FDA Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR