MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 7070000

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

No product was returned has been returned for evaluation nor were radiographs or photographs provided.Though no investigation could be conducted the complaint description and short period of time to failure suggest the root cause is an inter-operative incomplete assembly.Labeling review: ".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)." ".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." ".Screw he ad attachment with the screw head in the caddy, insert the head inserter into the rod slot and rotate the tri-lobe clockwise until tight (figs.67, 68).Prior to attaching the tulip to the screw head, confirm the push button on the head inserter is depressed and flush with the tri-lobe (fig.69).With the head inserter fully threaded into the screw head, align with the long axis of the screw shank and attach by applying downward force (fig.70) rotate the head inserter in a 360° orbital motion while applying downward force to facilitate screw head engagement (fig.71).Complete assembly has been achieved when the gold push button pops up from the tri-lobe just below the handle on the precept head inserter (fig.72).Not e if you feel the polyaxial tulip head has been assembled properly but the push button has not popped out, ensure the instrument is still threaded all the way into the polyaxial tulip head by rotating the tri-lobe clockwise.Then apply downward pressure to the instrument.".

Event Description

On (b)(6) 2017 a patient underwent a posterior lumbar interbody fusion procedure.On (b)(6) 2017 follow up radiographs showed a tulip separation at l3 level.On (b)(6) 2017 a revision procedure took place where the screw was removed and replaced with no reported issues.No patient injury reported.

Manufacturer Narrative

Product has been returned for investigation and the alleged event has been confirmed.A visual inspection was performed and heavy damaged was identified in the shank head.The short time to failure and damage observed is consistent with an incomplete assembly.

• Brand Name: NUVASIVE SPHERX II -MAS DEFORMITY SPINAL SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• 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: 7168520
• MDR Text Key: 97581170
• Report Number: 2031966-2017-00196
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517204028
• UDI-Public: 00887517204028
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102514
• 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,Followup
• Report Date: 05/15/2018

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: 7070000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/05/2018
• Supplement Dates Manufacturer Received: 05/11/2018
• Supplement Dates FDA Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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: 73 YR