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

Model Number 8800000006

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

Patient Problem Failure of Implant (1924)

Event Date 01/14/2016

Event Type  malfunction  

Manufacturer Narrative

No radiographs were provided to confirm the event and 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 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 in-situ.

Event Description

On (b)(6) 2015 a (b)(6) male underwent an xlif procedure at l2-s1 as well as posterior fixation at l2-s1.On (b)(6) 2015 a radiological examination determined that loosening of the set screw at s1 on the right side had taken place and a follow up radiologic exam on (b)(6) 2016 showed the right s1 set screw had disassociated form the tulip.Surgeon has elected to monitor the patient.No revision is currenly planned at this time.

• Brand Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Type of Device: NUVASIVE PRECEPT SPINAL SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: deborah silva ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 5458117
• MDR Text Key: 38991738
• Report Number: 2031966-2016-00008
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122352
• 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
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 8800000006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2016
• Initial Date FDA Received: 02/24/2016
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 79 YR