MAUDE Adverse Event Report: NUVASIVE, INCORPORATED; POSTERIOR CERVICAL SCREW SYSTEM

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Fall (1848)

Event Date 04/18/2023

Event Type  Injury  

Event Description

On unknown date a patient underwent posterior fixation procedure on unconfirmable levels of the spine.It was reported that some time post op the patient experienced a fall and as a consequence it was later discovered that two screws on a unknown side and level in the construct had pulled out of the vertebral body.On (b)(6) 2023 a revision occurred where the pulled out screws were replaced.It is unknown what else occurred during the revision and whether the patient experienced any adverse consequence as a result of the pulled out screws and subsequent revision.No additional details can be obtained.

Manufacturer Narrative

No product was received as the involved devices were disposed of at the user facility.No radiographs could be provided confirming alleged incident.It was confirmed in the initial reporting the patient has experienced a fall resulting in the root cause of the pulled out screws.No additional investigation required.Label 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." 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." ".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." h3 other text : device not returned.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The reported event was unable to be confirmed due to limited information received concerning this event.No device was returned to nuvasive for evaluation; further, no operative notes and/or radiograph images were provided for review of usage/technique.A review of manufacturing records was unable to be performed as the part and lot information of the product involved in the event was not available.A labeling review was unable to be performed as the nuvasive product involved was not provided.It was reported that the patient experienced a fall and subsequently the pulled out screws were identified.It is unknown if the patient's fall caused the screws to pull out or if the pulled out screws contributed to the fall event.A definitive root cause was unable to be determined with the information provided.If any further information is obtained that would change or alter any information provided, a supplemental report will be filed accordingly.

Event Description

N/a.

• Brand Name: NI
• Type of Device: POSTERIOR CERVICAL SCREW SYSTEM
• 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: 17344073
• MDR Text Key: 319233281
• Report Number: 2031966-2023-00145
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223181
• 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,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2023
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Prefer Not To Disclose