MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE VERSATIE SYSTEM; BONE FIXATION CERCLAGE, SUBLAMINAR

Model Number 86101245

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 09/22/2022

Event Type  Injury  

Manufacturer Narrative

Product was not returned and no images were provided to confirm the complaint.The root cause could not be determined though review of the reported event suggests a possible allergic reaction or possible band movement/ tissue irritation.Should more information become available a follow-up report will be completed.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.Potential risks identified with the use of this system, which may require additional surgery, include: infection, foreign body reaction to the implants." "warnings, cautions and precautions: implants can loosen, fracture, corrode, migrate, possibly increase the risk of infection, cause pain, or stress shield bone even after fracture has healed.If a device remains implanted after complete healing, it can actually increase the risk of refracture in an active individual.Therefore, these devices are temporary and should be removed after completing their intended function i.E., aiding in the bone healing process.The surgeon should weigh the risk versus benefit when deciding whether to remove an implant.Implant removal should be followed by adequate postoperative management to avoid refracture.If the patient is older, and has a low activity level, the surgeon may choose not to remove the implant, thus eliminating the risks associated with a second surgery.Care should be taken to insure that all components are ideally fixated prior to closure."pre-operative warnings: care should be used during surgical procedures to prevent damage to the devices and injury to the patient.".

Event Description

It was reported that approximately 6-8 months after implantation of versatie product, the patient developed an inflammatory reaction and possible unknown deficit.A removal procedure was performed where the versatie was removed and the patient continued with fusion with possible extension of construct.During removal, it was noted that the inflamed tissue was adjacent to the versatie tether.Per the reporter, there were no issues during initial implantation and surgical technique was followed.

• Brand Name: NUVASIVE VERSATIE SYSTEM
• Type of Device: BONE FIXATION CERCLAGE, SUBLAMINAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: geoff gannon ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 15611063
• MDR Text Key: 301814731
• Report Number: 2031966-2022-00204
• Device Sequence Number: 1
• Product Code: OWI
• UDI-Device Identifier: 00887517984296
• UDI-Public: 887517984296
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161265
• 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: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 86101245
• Device Lot Number: 220265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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): Other
• Patient Sex: Prefer Not To Disclose