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

Model Number 8890000

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 10/13/2015

Event Type  malfunction  

Manufacturer Narrative

The device was not returned but radiographs confirmed the reported event.The implant remains in-situ, and no further investigation can be completed at this time.It is unknown if the patient complied with post-operative instructions; surgeon reported the patient's weight and ability/willingness to comply with post-operative care were potential contributors.Root cause has not been determined, no conclusion can be drawn at this time.Labeling review notes the following: "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.Device remains in-situ.

Event Description

On (b)(6) 2015 a female patient was implanted with a precept spinal system at l5-s1 via the right side.The surgeon advised that films from the hospital on (b)(6) 2015 and office visit on (b)(6) 2015 show instrumentation intact and cage in place.Secondary review of these films noted the component separation was present on (b)(6) 2015.Follow-up films on (b)(6) 2015 confirmed that the left s1 tulip had disengaged from the screw shank.The cage was also shown to have migrated posteriorly.Revision surgery is planned for december to replace the screw and reposition the cage.

• Brand Name: PRECEPT SPINAL 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: 5272568
• MDR Text Key: 32869546
• Report Number: 2031966-2015-00072
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• 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

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: 8890000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/07/2015
• 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