MAUDE Adverse Event Report: NUVASIVE NUVASIVE RELINE SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 10100906

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned but a radiograph confirmed hook had loosened.The implant remains in-situ, and no further investigation can be completed at this time.It is unknown if the patient complied with postoperative instructions.Root cause has not been determined, no conclusion can be drawn.Review of labeling notes: warning cautions and precautions "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.

Event Description

On (b)(6) 2015 a female patient was implanted with the nuvasive reline system as an extension of a prior t10-ilium up to t6 surgery.On (b)(6) 2016 radiographs confirmed a hook back out.Surgeon elected to monitor the patient's condition.Device remains in-situ and patient is doing well with no reported injury or complications.No revision surgery is scheduled at this time.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): NUVASIVE; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: stacy gregory ; 7475 lusk blvd; san diego, CA 92121 ; 8587360313
• MDR Report Key: 5434224
• MDR Text Key: 38138526
• Report Number: 2031966-2016-00004
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial

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: Physician
• Device Model Number: 10100906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2016
• 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