MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number 8800000

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 08/06/2016

Event Type  malfunction  

Manufacturer Narrative

Review of radiographs suggest the rod may have been insufficiently seated prior to tightening or the rod size selected was too short resulting in locking down on the faceted rod end.This conclusion is supported by actions taken during revision surgery, in which a longer rod was selected and additional rod bending was performed as compared to the bend of the explanted rod."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." "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." device discarded at user facility.

Event Description

Following implantation of a lateral fusion/posterior fixation construct on (b)(6) 2016, it was noted that the right l4 lock screw had separated from the polyaxial screw.This was noted on (b)(6) 2016.Revision surgery to correct the component separation occurred shortly thereafter in which the rod and lock screw were replaced.No injury is known to have occurred.

• Brand Name: NUVASIVE SPHERX II -MAS DEFORMITY 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 Contact: paul holbrook ; 7475 lusk boulevard; san diego, CA 92121 ; 8583205285
• MDR Report Key: 5931189
• MDR Text Key: 54028953
• Report Number: 2031966-2016-00065
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517344076
• UDI-Public: 00887517344076
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K102514
• 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
• Report Date: 09/06/2016

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: 8800000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1