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

Model Number 8800000006

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 09/30/2015

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned.No radiographs confirming the event have been received.Review of the device history record shows no material non-conformances or manufacturing errors that may have caused or contributed to this mode of failure.Review of labeling notes: 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.Care should be taken to insure that all components are ideally fixated prior to closure.All implants should be used only with the appropriately designated instrument (reference surgical technique).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.Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed.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.

Event Description

On (b)(6) 2014, a (b)(6) old male underwent a tlif procedure at l4/5 and l5/s1.In (b)(6) 2015 patient developed back pain; examination noted the right l4 set screw had disassociated from the remaining construct.Revision surgery occurred on (b)(6) 2015 in which the affected set screw and rod were replaced.Patient reported as doing well following construct revision.

• 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: 5174811
• MDR Text Key: 29213466
• Report Number: 2031966-2015-00062
• 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: 10/23/2015

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
• Device Lot Number: JP8242
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2015
• 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: 56 YR