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

Model Number 8800000006

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2015

Event Type  malfunction  

Manufacturer Narrative

The device remains in-situ.No radiographs were provided to confirm the event.It is unknown if the patient complied with post-operative instructions or was subjected to an impact that may have contributed to the event.The surgery reportedly involved the use of another manufacturer's product; this may also have contributed to the event.No further investigation can be completed at this time.Root cause has not been determined and 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:.Bending or loosening of implant, loss of fixation." "care should be taken to insure that all components are ideally fixated prior to closure." "confirm heights of screws match with patient's lordosis when securing lock screws.Failure to verify screw height following insertion may result in inadequate rod normalization.Final-tighten all lock screws with the counter-torque and torque t-handle.Do not final-tighten through other instruments in the set, as the rod may not be able to normalize to the tulip.Ensure there is enough rod overhang when final tightening, and do not lock down on the conical portion of the rod.Failure to do so may lead to improper lock down of the construct.It may be necessary for the surgeon to add length to the rod, depending upon patient anatomy and desired lordosis." "compatibility: do not use the precept spinal system with components of other systems.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system." device was left in-situ.

Event Description

On (b)(6) 2015 a (b)(6) year old female underwent an xlif procedure at l3-l5 with posterior lumbar fixation at l5-s1.Precept posterior fixation at l3-5 (note: paradigm spine msdj device at l5/s1.On (b)(6) 2015 a radiological examination determined that loosening of the set screw at s1 on the right side.A follow up radiologic examination on (b)(6) 2016 showed the right s1 set screw had separated from the remaining construct.No revision is currently planned; the patient will continue to be monitored by the surgeon.No patient injury has been reported.

• Brand Name: NUVASIVE PRECEPT SPINAL 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: 5452829
• MDR Text Key: 39363721
• Report Number: 2031966-2016-00010
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• 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
• 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
• Patient Age: 64 YR