MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE OCT SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION

Model Number	7906300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The explanted components were reportedly discarded following revision surgery.The patient was reported to have a congenital bone deformity condition.The patient was reported to have limited mobility and that no impacts had been sustained.Films received show the initial surgery date was (b)(6) 2015.The construct extended from the occiput to the mid-thoracic spine without cervical fixation.Manufacturing records indicate dimensional requirements were met.The material type and tensile characteristics conform with specifications.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"."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." explants were discarded at user facility.
Event or Problem Description
Posterior cervical fixation was implanted into a patient with a congenital bone deformity condition on (b)(6) 2015.The initial construct was reported to extend from the occiput to the mid-thoracic spine.On (b)(6) 2016 the construct was revised due to bilateral rod fracture at approximately the c7 spine level.

• Brand Name: NUVASIVE OCT SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6062775
• Report Number: 2031966-2016-00080
• Device Sequence Number: 76133
• Product Code: MNI
• UDI-Device Identifier: 00887517184535
• UDI-Public: 00887517184535
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/27/2016

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: 7906300
• Device Lot Number: CT1492
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2016
• Initial Report FDA Received Date: 10/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 YR