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

Model Number	16087545
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation nor were bone quality tests result provided; however, radiographs provided confirmed the reported event.It is unknown if the patient complied with post-operative physical restrictions.At this time there is insufficient information to determine the root cause.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)." ".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.".
Event or Problem Description
In (b)(6) 2018, a patient underwent a procedure from vertebral level l2 to l4.Screws were placed percutaneously to brace a fracture.During a follow up appointment in (b)(6) 2019, radiographs identified that the screws had loosened prematurely and would need to be removed.On (b)(6) 2019, the patient underwent a revision procedure.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE; 7475 lusk boulevard; san diego 92121
• MDR Report Key: 8893933
• Report Number: 2031966-2019-00228
• Device Sequence Number: 241018
• Product Code: NKB
• UDI-Device Identifier: 00887517560056
• UDI-Public: 887517560056
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2019

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: 16087545
• Device Lot Number: AS6839
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR