MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE DECADE LATERAL PLATE SYSTEM; AAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	7145540
Medical Device Problem Codes	Fracture (1260); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	03/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor were radiographs or images provided to confirm the alleged event.It is unknown if patient followed post-operative restrictions or suffered a fall.At this time no root cause can be identified.Labeling review: "potential adverse events and complications: infrequent operative and postoperative complications that may result in the need for additional surgeries include: bending, fracture or loosening of implant component(s)." "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." "patient education: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: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration 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.".
Event or Problem Description
A patent underwent a retroperitoneal procedure at l3-l4 levels on (b)(6) 2018.On (b)(6) 2019 postoperative radiographs indicated two broken screws/ hardware in the thoracic spine.On (b)(6) 2019 the patient underwent a revision procedure to remove all previous implanted hardware and replaced with an entire new system.
Additional Manufacturer Narrative
Even though root cause cannot be confirmed, a review of the reported event identifies that nuvasive devices were combined with two other manufactures products which is not recommended as they are untested and unexpected results maybe experienced.The patient is noted as having a history of spine surgery and associated pain.
Event or Problem Description
On (b)(6) 2019, a patient underwent a revision procedure at l4 to replace two broken screws from another manufacturer without a reported issue.On (b)(6) 2019, the patient was seen for pain and radiographs identified two broken screws as well as continued pathology up to t2.On (b)(6) 2019, the patient underwent a revision procedure to remove all previous implanted hardware and replaced with an entire new system.

• Brand Name: NUVASIVE DECADE LATERAL PLATE SYSTEM
• Common Device Name: AAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 10062505
• Report Number: 2031966-2020-00086
• Device Sequence Number: 14109725
• Product Code: KWQ
• UDI-Device Identifier: 00887517317452
• UDI-Public: 887517317452
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K130868
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2020

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: 7145540
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/15/2020
• Supplement Report FDA Received Date: 11/06/2020
• 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; Other; Required Intervention
• Patient Age: 14 YR