MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE BASE INTERFIXATED TITANIUM SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number	6955172
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Pain (1994)
Date of Event	02/07/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.No allegation of product failure observed.Review of the radiographs and alleged report indicate confirmation of proper placement as well as symptom relief was achieved.Review also describes the placement of another manufacturer's posterior fixation involving some form of applied compression end resulted in cage movement and subsequent screw breach.Post revision screw removal the patient is reported to be doing well.Labeling review: ".Insert centering pin into midline (fig.2).Use a/p fluoro to verify midline and lateral fluoro to check depth (fig.3).The length of the centering pin is 20 mm." ".When implant is in proper position, select desired hex handle (straight or t) and awl (straight or angled) and place over the proximal end of awl shaft.Once awl is secured, set awl depth stop to zero and place into desired guide tube and bolt pocket.When the awl is bottomed out in the bolt pocket, select 15 mm awl depth on depth stop and proceed to deploy awl.Awl will deploy at nominal cranial/caudal bolt trajectory of 35°.Confirm proper depth and trajectory on lateral fluoro imaging.Awl is fully seated into bolt hole when green fluorescent color band on distal end of awl disappears into guide tube." ".Potential risks identified with the use of this system, which may require additional surgery, include: · bending, fracture or loosening of implant component(s) · loss of fixation · nonunion or delayed union · fracture of the vertebra · neurological, vascular or visceral injury · metal sensitivity or allergic reaction to a foreign body · infection · decrease in bone density due to stress shielding · pain, discomfort or abnormal sensations due to the presence of the device" ".Compatibility: do not use base interfixated system with components of other systems.Unless stated otherwise nuvasive devices are not to be combined with the components of another system." ".It is important to select the appropriate length base interfixated screw and confirm trajectory under intraoperative fluoroscopy in order to avoid potential screw impingement.".
Event or Problem Description
On (b)(6) 2018 a patient underwent an anterior lumbar interbody fusion at l5/s1 levels with disc arthroplasty at l4/l5 without any reported issues.As per reporter patient woke up with alleviated symptoms and radiographs were clear.On (b)(6) 2018 patient received posterior fixation at l5/s1 utilizing another manufacturer's hardware and navigation.Patient awoke in pain, a post-operative ct scan identified a spinal canal breach at l5 level by one of the superior interfixated screws.An immediate anterior procedure was performed to remove the impending screw leaving one superior and one inferior screw.Patient noted as doing well post revision procedure.No allegation of product malfunction related to nuvasive products.

• Brand Name: NUVASIVE BASE INTERFIXATED TITANIUM SYSTEM
• Common Device Name: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 7306930
• Report Number: 2031966-2018-00018
• Device Sequence Number: 1343108
• Product Code: OVD
• UDI-Device Identifier: 00887517802736
• UDI-Public: 00887517802736
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K170592
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2018

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?: No
• Operator of Device: Physician
• Device Model Number: 6955172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 03/01/2018
• 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: Required Intervention