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

Model Number	15355300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product was returned and no evaluation could be completed.Provided radiographs confirm the alleged malfunction.It is unknown if the patient followed post-operative restrictions or suffered a fall.It is unknown if fusion was completed.No root cause can be determined and no additional investigation can be completed at this time.Labeling review: ".Potential adverse events and complications: as with any major surgical procedures, there are risks involved in orthopedic surgery.Rarely, some complications may be fatal.Potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".Warnings, cautions and precautions: these devices can break when subjected to the increased load associated with delayed union or nonunion.If healing is delayed, or does not occur, the implant may eventually loosen, bend, or break.Loads on the device produced by load bearing and by the patient¿s activity level will dictate the longevity of the implant." ".: patient education: 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." ".Post-operative warnings: damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications." device not returned.
Event or Problem Description
On (b)(6) 2020 during a second revision surgery for a broken right rod, it was discovered that the left side rod between l5/s1 was broken.
Event or Problem Description
The device was returned and evaluated, updated information can be found in sections:.

• Brand Name: NUVASIVE RELINE SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE, INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• MDR Report Key: 10852879
• Report Number: 2031966-2020-00205
• Device Sequence Number: 14495380
• Product Code: NKB
• UDI-Device Identifier: 00887517509949
• UDI-Public: 887517509949
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2020

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: 15355300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 11/17/2020
• Supplement Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 105