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

Device Problem Fracture (1260)

Patient Problem Failure of Implant (1924)

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

No product was returned for evaluation; screw remains in-situ.No material number or lot information has been received.No patient information provided.No radiographs provided.It is not known if the patient complied with post operative instructions or suffered a fall.No revision is planned at this time.The root cause of this reported event has not been determined.Labeling review: ".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) loss of fixation" ".Warnings, cautions and precautions: correct selection of the implant is extremely important.The potential for success is increased by the selection of the proper size of the implant.The vuepoint oct system can also be linked to ø3.5 mm - ø6.25 mm rods of posterior pedicle screw and rod systems via the rod to rod connectors or transition rods.While proper selection can minimize risks, the size and shape of human bones present limitations on the size and strength of implants.Metallic and internal fixation devices cannot withstand the activity levels and/or loads equal to those placed on normal, healthy bone.These devices are not designed to withstand the unsupported stress of full weight or load bearing alone." '.Patient education: preoperative instructions to the patient are essential.The patient should be made aware of the limitations of the implant and potential risks of the surgery.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." still in patient.

Event Description

An unknown patient reported post-op screw fractures at c1 and c2 during the week of (b)(6) 2016, the original surgery date, material numbers and patient condition are unknown.No injury has been reported.

• Brand Name: NUVASIVE OCT SYSTEM
• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd; san diego, CA 92121 ; 8588825019
• MDR Report Key: 5662200
• MDR Text Key: 45367107
• Report Number: 2031966-2016-00042
• Device Sequence Number: 1
• Product Code: MNI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/17/2016

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
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2016
• Initial Date FDA Received: 05/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1