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

Model Number	13117545
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	07/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has been received and visual inspection indicates final lock down was achieved.X-rays films provided confirm the alleged event.Root cause has not been identified.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)." 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." ".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.".
Event or Problem Description
On (b)(6) 2019 patient underwent a fusion procedure on l4 to s1 vertebral levels.As per reporter the procedure was successful with no reported issues.Patient reported to have experienced bad coughing and sneezing and felt a pop.During a 6 week follow up appointment it was discovered via xray that the rods were damaged and a screws back out.Patient underwent a revision procedure on (b)(6) 2019 where all screws and rods were removed.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 8878471
• Report Number: 2031966-2019-00225
• Device Sequence Number: 2048693
• Product Code: NKB
• UDI-Device Identifier: 00887517582782
• UDI-Public: 887517582782
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 13117545
• Device Lot Number: SA3082
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2019
• Initial Report FDA Received Date: 08/09/2019
• 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: Hospitalization
• Patient Age: 65 YR
• Patient Weight: 113