MAUDE Adverse Event Report: 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 Failure of Implant (1924)

Event Date 04/22/2016

Event Type  malfunction  

Manufacturer Narrative

Radiographs were received and the loosening/separation was confirmed.The device remains in-situ.It is unknown if the patient complied with post-operative instructions or suffered an impact that may have contributed to the event.It cannot be determined if the lock screws were tightened fully during the index surgery.No further investigation can be completed at this time.Root cause has not been determined and no conclusion can be drawn.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 device system, which may require additional surgery include: device component fracture, bending or loosening of implant, loss of fixation, fracture of the vertebra" warnings, cautions and precautions: "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.".

Event Description

On (b)(6) 2015, a female patient underwent a plif procedure at l5-s1 to treat lumbar spinal stenosis.A cage was placed at l5-s1.On (b)(6) 2016, radiographs showed a possible set screw loosening at the right s1 position.On (b)(6) 2016, set screw separation at right and left s1 was confirmed as well as loosening at the left l5.The patient is asymptomatic and there appears to be a solid fusion at l5-s1.The surgeon has elected to monitor the patient and no revision surgery is planned at this time.No patient injury was reported.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer Contact: stacy gregory ; 7475 lusk blvd; san diego, CA 92121 ; 8587360313
• MDR Report Key: 5668185
• MDR Text Key: 45578340
• Report Number: 2031966-2016-00044
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8800000006
• Device Lot Number: JP9419
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/08/2015
• 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