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

Model Number 8439560

Device Problems Misconnection (1399); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 12/08/2015

Event Type  malfunction  

Manufacturer Narrative

No product returned left in-situ.The degree of spinal instability is unknown.Patient's bone quality was unknown.No revision is planned at this time; the patient will continue to be monitored.The root cause of this reported event has not been determined.Labeling review: 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.Device has not been returned.

Event Description

On (b)(6) 2015 a female patients post-operative radiolographs showed the left-side iliac screw components had separated.No additional information has been provided.No injury has been reported.

• Brand Name: NUVASIVE SPHERX II - PEDICLE SCREW SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd; san diego, CA 92121 ; 8588825019
• MDR Report Key: 5352213
• MDR Text Key: 35315685
• Report Number: 2031966-2015-00089
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517252654
• UDI-Public: 00887517252654
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8439560
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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