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

Model Number	16186535
Medical Device Problem Code	Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not received by nuvasive as it is still in-situ.No radiographic images have been provided.The patients bone quality is unknown.It is unknown if fusion has occurred.Review of the information received via phone conversation with the patient as well as the provided surgeons notes outline the patient has lower back and extremity pain appear to be continued pathology.No root cause can be identified at this time.Labeling review: ".Preoperative warning: care should be used in the handling and storage of the implants.The implants should not be scratched or damaged.Implants and instruments should be protected during storage and from corrosive environments.".All non-sterile parts should be cleaned and sterilized before use.Devices should be inspected for damage prior to implantation.Care should be used during surgical procedures to prevent damage to the device(s) and injury to the patient." ".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." ".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), loss of fixation, nonunion or delayed union.".
Event or Problem Description
A patient reported via voicemail to have underwent a transforaminal lumbar interbody fusion procedure, laminectomy at l4-5 and l5-s1 levels with posterior fixation from l4 -s1 with electropysiologic monitoring, along with complete right sided facetectomies and left posterolateral arthrodesis and fusion on (b)(6) 2019.Less than a year later the patient began to experience pain which has continued to date.A post-operative ct scan identified two loose screws at unconfirmed positions.

• 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: 10243183
• Report Number: 2031966-2020-00142
• Device Sequence Number: 2228626
• Product Code: NKB
• UDI-Device Identifier: 00887517654847
• UDI-Public: 887517654847
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/07/2020

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: 16186535
• 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: 06/12/2020
• Initial Report FDA Received Date: 07/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 38 YR