MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number	13014545
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/11/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Radiographs were not provided to confirm the event.The explanted product was not returned for evaluation.Review of the procedural information provided acknowledged the use of a non-nuvasive probe of undisclosed size for placement of pedicle screws.Labeling review: ".Contraindications: contraindications include but are not limited to: infection, local to the operative site.Signs of local inflammation.Patients with known sensitivity to the materials implanted.Patients who are unwilling to restrict activities or follow medical advice.Patients with inadequate bone stock or quality." ".All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through compression instruments (e.G.C/d rack and figure 8 compressor) in the set, as the rod may not be able to normalize to the tulip.Be cautious not to over compress or distract as you can loosen the screws in the spine and potentially pull out the screw." ".Preoperative warnings: only patients that meet the criteria described in the indications should be selected.Patient condition and/or predispositions such as those addressed in the aforementioned contraindications should be avoided.Care should be used in the handling." ".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 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." ".The safety and effectiveness of this device has not been established when used in conjunction with bone cement or for use in patients with poor bone quality (e.G., osteoporosis, osteopenia)." ".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." ".Compatibility: do not use reline system with components of other systems than armada system.Refer to the armada system instructions for use for a list of the armada system indications of use.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system.All implants should be used only with the appropriately designated instrument (reference surgical technique).Iliac screws have a single lead thread on the shaft and must be used with single lead taps to ensure proper purchase in bone.".
Event or Problem Description
Post-operative follow up identified 4 screws backed out at t10-12 levels and as a result the tip of the left side rod protruded through the incision site.On (b)(6) 2017, a revision surgery was performed replacing the 4 screws at t10-t12 levels.The protruded rod tip was bent ventrally and the surgical site was washed to deter infection.No additional issues or injury reported.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 6775087
• Report Number: 2031966-2017-00101
• Device Sequence Number: 16276452
• Product Code: NKB
• UDI-Device Identifier: 00887517536495
• UDI-Public: 00887517536495
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2017

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: 13014545
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2017
• Initial Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1