MAUDE Adverse Event Report: NUVASIVE NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 13550000

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation as product remains in-situ.Radiographs provided confirmed the alleged event.It is unknown if patient followed post-operative activity restrictions.Root cause of the reported event is unknown at this time.No revision procedure is planned at this time.Labeling review: potential adverse events and complications ".As with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection; damage to blood vessels, spinal cord or peripheral nerves; pulmonary emboli; loss of sensory and/or motor function; impotence; and permanent pain and/or deformity.Rarely, some complications may be fatal.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, nonunion or delayed union." warnings, cautions and precautions: ".All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments (e.G.C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip.Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw." ".These devices can break when subjected to the increased load associated with delayed union or nonunion.Internal fixation appliances are load-sharing devices that hold bony structures in alignment until healing occurs.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." patient education: ".Preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.The patient should be instructed to limit postoperative activity, as this will reduce the risk of bent, broken or loose implant components.The patient must be made aware that implant components may bend, break or loosen even though restrictions in activity are followed." post-operative warnings: ".During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.".

Event Description

On (b)(6) 2019, a patient underwent a spinal procedure at l4 to l5 levels.During a routine follow up, radiographs identified that the lock screws had disengaged from the engaged tulip.Patient is asymptomatic and no revision procedure is planned at this time.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: yobana sanchez ; 7475 lusk boulevard; san diego, CA 92121 ; 8589093383
• MDR Report Key: 9281466
• MDR Text Key: 167982608
• Report Number: 2031966-2019-00250
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517551702
• UDI-Public: 887517551702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K182974
• 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: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 13550000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2019
• 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
• Patient Age: 76 YR