MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE MODULUS ALIF SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number 1921050P2

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 03/15/2023

Event Type  malfunction  

Manufacturer Narrative

No device has been returned for evaluation at this time, a lateral radiograph was provided confirming the migrated cage.The patient was not reported to have experienced any falls, post op physical activity levels could not be confirmed.The involved torque handle has not been returned for evaluation at this time.Due to the lack of information provided a root cause could not be determined but a review of the reported information and similar reported events suggests possible insufficient final torque applied, rod interference related to insufficient reducing/normalization, implant selection and placement and/or excessive post operative activity as cause or contributors to the event.No lot number could be provided so a review of the manufacturing history could not be performed.No additional investigation can be completed at this time, should more information be received a follow-up report will be completed.Label review ¿¿ potential adverse events and complications as with any major surgical procedures, there are risks involved in spinal/orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries¿ 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¿¿ ¿¿ warnings, cautions and precautions - 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¿¿ ¿¿ care should be taken to ensure 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¿¿.

Event Description

On (b)(6) 2023 a patient underwent an anterior lumbar interbody fusion with posterior fixation from l5 to s1.The surgery was completed without issue.On (b)(6) 2023 it was discovered during a follow up appointment that the interbody had migrated anteriorly and one of the superior lock screws appeared to have backed out (b)(6).The patient was reported to have had no adverse consequences as a result of the migrations.On (b)(6) 2023 a revision occurred where the migrated interbody and backed out lock screw were replaced.The patient is reported to be doing well post revision.

• Brand Name: NUVASIVE MODULUS ALIF SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 16725832
• MDR Text Key: 313647791
• Report Number: 2031966-2023-00069
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 00887517020239
• UDI-Public: 887517020239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210271
• 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: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1921050P2
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/15/2023
• Initial Date FDA Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: 1450200, ALIF FIXATION BOLT.
• Patient Age: 70 YR
• Patient Sex: Male