MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE PRECEPT SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 8890000

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

A review of radiographs has been performed.The evaluation of the explanted device found markings that indicate an incomplete assembly in-situ causing the post-operative disassembly.The patient remains asymptomatic.Review of the device history record notes no material nonconformance's, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure.Parts met acceptance criteria upon release.Labeling review: "warning and cautions and precautions, 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 and visceral injury.If healing is delayed, or does not occur, the implant may eventually loosen, bend or break.Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant." "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).".

Event Description

On (b)(6) 2018 a patient underwent a transforaminal lumbar interbody fusion procedure at l5-s1 levels with no issues reported.On (b)(6) 2018 during follow up radiographs revealed a tulip separation at the s1 right side level.On (b)(6) 2018 a revision procedure was completed where the screw was replaced with no additional issue reported.No patient harm or injury reported.

• Brand Name: NUVASIVE PRECEPT 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: 7567682
• MDR Text Key: 110043386
• Report Number: 2031966-2018-00094
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517385604
• UDI-Public: 00887517385604
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: 8890000
• Device Lot Number: JP15166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2018
• 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: 59 YR