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

Model Number 8450001

Device Problem Material Rupture (1546)

Patient Problem Pain (1994)

Event Date 07/10/2020

Event Type  malfunction  

Manufacturer Narrative

No product has been returned for evaluation, pictures and films confirmed the alleged event.The patients activity levels could not be confirmed.It is unknown if fusion was achieved.No root cause has been established at this time.".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: disassembly, fraying, kinking, loosening, bending or breakage of any or all of the versatie system implant components, loss of fixation, pain, discomfort or abnormal sensations due to the presence of the device." ".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.Metallic and polyester internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone." ".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.The risk of bending, loosening or breakage of a temporary internal fixation device during postoperative rehabilitation may be increased if the patient is active, or if the patient is debilitated, demented, or otherwise unable to use crutches or other weight supporting devices." ".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 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

Patient underwent a revision procedure on (b)(6) 2019, where the construct was extended to the t10 level.The patient began to experience pain at the top of the construct.A revision procedure was performed on (b)(6) 2020.As per reporter, it was confirmed that 4 of the 6 implanted bands had ruptured, which in turn had loosened the constructs screws.The patient reported no issues post the revision procedure.

Manufacturer Narrative

The product was received the alleged event of ruptured was confirmed.The root cause of the issue is unknown, but may be the result of excessive post operative activity, insufficient bone prep, excessive construct loading or excessive tension applied during placement.Surgeon follow up and review was completed.

• Brand Name: NUVASIVE VERSATIE SYSTEM
• Type of Device: BONE FIXATION CERCLAGE, SUBLAMINAR
• Manufacturer (Section D): NUVASIVE INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 10377330
• MDR Text Key: 202006751
• Report Number: 2031966-2020-00155
• Device Sequence Number: 1
• Product Code: OWI
• UDI-Device Identifier: 00887517709875
• UDI-Public: 887517709875
• Combination Product (y/n): N
• PMA/PMN Number: K190418
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8450001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 70