MAUDE Adverse Event Report: NUVASIVE NUVASIVE VUEPOINT OCT SYSTEM; APPLIANCE, FIXATION, SPINAL INTERLAMINAL

Model Number	7905326
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation as product remains in-situ.Radiographs provided confirmed the reported event.As per reporter, it is believed patient condition can have contributed to the event.Labeling review: contraindications: "contraindications include, but are not limited to: patients who are unwilling to restrict activities or follow medical advice; patients with inadequate bone stock or quality." potential adverse events and complications: "as with any major surgical procedures, there are risks involved in orthopedic surgery.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." patient education: "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." post-operative warnings: "during the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications.To ensure the earliest possible detection of such catalysts of device dysfunction, the devices must be checked periodically postoperatively, using appropriate radiographic techniques.".
Event or Problem Description
On (b)(6) 2018, a patient underwent cervical procedure.As per reporter approximately 10 months post operative, radiographs indicated a screw breakage.A revision procedure is being planned but has not been confirmed.No patient injury has been reported.

• Brand Name: NUVASIVE VUEPOINT OCT SYSTEM
• Common Device Name: APPLIANCE, FIXATION, SPINAL INTERLAMINAL
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 9157216
• Report Number: 2031966-2019-00241
• Device Sequence Number: 1971689
• Product Code: KWP
• UDI-Device Identifier: 00887517179326
• UDI-Public: 887517179326
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K093319
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2019

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: Health Professional
• Device Model Number: 7905326
• Device Lot Number: JK13685
• 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: 09/10/2019
• Initial Report FDA Received Date: 10/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR