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

Model Number 3900240

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

The exact implant date is unknown but likely (b)(6) or (b)(6) 2023, based on the information obtained.Concomitant products include: reline c handle, torque 26in-lbs.No device was returned as the implant remains in-situ.Radiographs were provided, which were used to confirm the reported event.From the radiographs it can be seen that the two (2) lock screws on the t1 pedicle screw tulips have backed out of proper position.Based on the information obtained the root cause of the reported event is unknown, but may be the result of the associated torque handle used for final tightening not meeting the required torque limiting specification.A follow-up report will be provided if additional information becomes available.Labeling review: ".Care should be taken to insure that all components are ideally fixated prior to closure." ".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." ".Warnings, cautions and precautions: care should be taken to insure that all components are ideally fixated prior to closure.".

Event Description

During a six (6) week postoperative follow-up with a patient that had undergone a cervical fixation procedure, it was found that two (2) lock screws had backed out of the pedicle screw tulips at t1.All other screws in the construct appeared to be in the correct positions.No revision procedure is scheduled at this time.Medwatch 2 of 2.

• Brand Name: NUVASIVE RELINE CERVICAL SYSTEM
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoffrey gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 16742888
• MDR Text Key: 313318680
• Report Number: 2031966-2023-00081
• Device Sequence Number: 1
• Product Code: NKG
• UDI-Device Identifier: 00195377068064
• UDI-Public: 195377068064
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3900240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/16/2023
• 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
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 67 KG