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

Model Number	8806545A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation.Copy of x-ray films have been provided and alleged event could not be confirmed.Labeling review: 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)." ".Use lateral fluoroscopy to properly manage the k-wire during pedicle preparation to ensure proper placement and avoid anterior advancement of the k-wire." ".Confirm heights of screws match with patient's lordosis when securing lock screws.Failure to verify screw height following insertion may result in inadequate rod normalization." ".Final-tighten all lock screws with the counter-torque and torque t-handle.Do not final-tighten through other instruments in the set, as the rod may not be able to normalize to the tulip.Ensure there is enough rod overhang when final tightening, and do not lock down on the conical portion of the rod.Failure to do so may lead to improper lock down of the construct." 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." no product returned remains in-situ.
Event or Problem Description
On (b)(6) 2018 patient underwent a surgical procedure to address a fracture on the t12 vertebral body with no reported incidents.Two weeks post-operative x-rays films showed screw(s) back out.No revision procedure is planned at this time.

• Brand Name: NUVASIVE POLYAXIAL SPINAL SCREWS
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE; 7475 lusk blvd; san diego 92121
• MDR Report Key: 8267780
• Report Number: 2031966-2019-00154
• Device Sequence Number: 2126759
• Product Code: NKB
• UDI-Device Identifier: 00887517450654
• UDI-Public: 887517450654
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K121619
• 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): 01/22/2019

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: 8806545A
• 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: 12/24/2018
• Initial Report FDA Received Date: 01/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR