MAUDE Adverse Event Report: NUVASIVE, INCORPORATED NUVASIVE TRAVERSE PLATE SYSTEM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number	7835545
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned for evaluation, lateral films confirm the screw back out.The type and root cause of the infection could not be confirmed.".Potential adverse events and complications - potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)¿" ".Important: prior to locking bone screws into the plate, ensure that all bone screws are inserted (driven) 75% into bone prior to final tightening.Failure to do so may reduce the chance of properly locking the bone screw into the plate construct." ".The correct trajectory of the screws helps to ensure proper screw placement and lock.¿".
Event or Problem Description
On (b)(6) 2020 patient underwent a lateral interbody fusion corpectomy procedure.On a unknown date it was discovered that the patient had an infection that was seemingly localized by a screw in the construct.When brought in to address the infection it was discovered that there was a screw backing out.A revision procedure was performed on (b)(6) 2020 where a wash out was performed and the backed screw was removed posteriorly after resecting a rib.

• Brand Name: NUVASIVE TRAVERSE PLATE SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 10738463
• Report Number: 2031966-2020-00196
• Device Sequence Number: 3450618
• Product Code: KWQ
• UDI-Device Identifier: 00887517155931
• UDI-Public: 887517155931
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K103750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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: 7835545
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/26/2020
• 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