MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE POLYAXIAL SPINAL SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	8805555A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation.A review of radiographic films have been reviewed and confirm the screw fracture.Information received indicates a non nuvasive product was used to pack the coroent cages.Labeling review: ".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." ".To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques." ".Contraindications include but are not limited to: use with components of other systems." ".Compatibility: do not use the precept spinal system with components of other systems.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system." no product returned for investigation.
Event or Problem Description
Received information stating patient underwent an extreme lateral interbody fusion procedure on (b)(6) 2015, with uni lateral precept screws using medtronic bone morphogenetic proteins to pack coroent cages.On (b)(6) 2017, radiograph showed a broken screw at the l4 mid pedicle level.It is unknown if patient underwent a revision surgery at this time.

• Brand Name: NUVASIVE POLYAXIAL SPINAL SCREWS
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6795511
• Report Number: 2031966-2017-00107
• Device Sequence Number: 19082562
• Product Code: NKB
• UDI-Device Identifier: 00887517449788
• UDI-Public: 00887517449788
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K121619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 8805555A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2017
• Initial Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1