MAUDE Adverse Event Report: NUVASIVE, INC. ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASENI; 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 11/12/2015

Event Type  malfunction  

Manufacturer Narrative

The device was not returned but radiographs confirmed screw back out.The implant was discarded by the hospital 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.".

Event Description

On (b)(6) 2015 a patient underwent a lumbar posterior fixation at l4-l5.After surgery examination noted disassociation of the set screw at right l4.Revision surgery occurred on (b)(6) 2015 and the set screw was replaced.No patient injury is known to have occurred.

• Brand Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASENI
• 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 ; 8589091830
• MDR Report Key: 5316009
• MDR Text Key: 34039672
• Report Number: 2031966-2015-00071
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517344076
• UDI-Public: 00887517344076
• 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: 12/15/2015

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: Physician
• Device Model Number: 8800000006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/21/2015
• 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