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

Model Number	8510260
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation radiographs and pictures confirm alleged event.Provided information suggests that the rupture of the bands caused the construct to become undone.No root can be confirmed at this time.Device not returned.
Event or Problem Description
It was reported patient was experiencing pain post-operative at the top of the construct and radiographs revealed that implanted bands ruptured.During the revision procedure the surgeon noted that 3 of the 4 implanted bands had ruptured, which in turn had loosened the constructs.
Additional 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.Labeling review: ".Potential adverse events and complications 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.Nonunion or delayed union.Pain, discomfort or abnormal sensations due to the presence of the device." ".Warnings, cautions, and precautions 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.".

• Brand Name: NUVASIVE VERSATIE SYSTEM
• Common Device Name: BONE FIXATION CERCLAGE, SUBLAMINAR
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk blvd.; san diego CA 92121
• MDR Report Key: 10394512
• Report Number: 2031966-2020-00156
• Device Sequence Number: 14129542
• Product Code: OWI
• UDI-Device Identifier: 00887517794857
• UDI-Public: 887517794857
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161265
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8510260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/12/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization