MAUDE Adverse Event Report: NUVASIVE INC. NUVAISVE RELINE CERVICAL SYSTEM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number 3704518

Device Problems Fracture (1260); Migration or Expulsion of Device (1395)

Patient Problem Neck Pain (2433)

Event Date 10/01/2020

Event Type  malfunction  

Manufacturer Narrative

The product was received and the complaint was confirmed.The patient post operative activity is unknown.The provided radiographs and device were evaluated and a bending fracture and screw pull out was confirmed.The root cause is considered to be a malplacement as it appears that the c2 translaminar screw was inserted and contacted the previously placed c2 pedicle screw, which augured the bone allowing the subsequent pull out of bone.The backed out screw became overloaded and fractured.No additional investigation required.Labeling review: ".Contraindications: contraindications include, but are not limited to: 4.Patients who are unwilling to restrict activities or follow medical advice.5.Patients with inadequate bone stock or quality.6.Patients with physical or medical conditions that would prohibit beneficial surgical outcome." ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component." ".The implantation of spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient." ".Correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants." ".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

A patient underwent a cervical spinal procedure on an unknown date in (b)(6) 2020.On an unknown date it was discovered the patient experienced a screw fracture at c2.The patient is very symptomatic on (b)(6) 2021 a revision was completed without a reported issue.

• Brand Name: NUVAISVE RELINE CERVICAL SYSTEM
• Type of Device: POSTERIOR CERVICAL 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: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 11748721
• MDR Text Key: 253115547
• Report Number: 2031966-2021-00060
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 00887517007452
• UDI-Public: 887517007452
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K191553
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3704518
• Device Lot Number: JP19846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• 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: 62 YR