MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE POLYAXIAL SPINAL SCREWS; PEDICLE SCREW SPINAL SYSTEM

Model Number 8847045

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 11/24/2015

Event Type  malfunction  

Manufacturer Narrative

Radiographs were received confirming the event.Currently no plan for revision, the patient will continue to be monitored.No product will be returned; no further evaluation of the product can be completed at this time.Patient's bone quality is unknown; the degree of spinal instability is unknown.The root cause of the event has not been determined.Review of labeling notes: "warnings cautions and precautions 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).Use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to ensure proper placement and avoid anterior advancement of the k-wire.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.The screw dilator cannot be used to sequentially dilate around the tap-dilator combo.Therefore, the screw should be inserted without a dilator.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 was left in patient.

Event Description

On (b)(6) 2015 a patient underwent a procedure to implant posterior fixation from l1 to s1.No problems were noted during the procedure, however immediate post-op films showed a possible rod separation at left s1.No revision is planned at this time and no patient injury was reported.

• Brand Name: NUVASIVE POLYAXIAL SPINAL SCREWS
• Type of Device: PEDICLE SCREW SPINAL 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: 5320450
• MDR Text Key: 34175111
• Report Number: 2031966-2015-00080
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517377548
• UDI-Public: 00887517377548
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121619
• 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: 12/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8847045
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2015
• 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