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

Model Number	11104055
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned for investigation nor were radiographs provided to confirm the alleged event.No root cause can be identified at this time.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)." post-operative warnings ".During the postoperative phase it is of particular importance that the physician keeps the patient well informed of all procedures and treatments.Damage to the weight-bearing structures can give rise to loosening of the components, dislocation and migration, as well as to other complications." ".Compatibility: do not use the reline system with components of other systems, other than the armada system.Refer to the armada system instructions for use for a list of the armada system indications for use.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system.".
Event or Problem Description
A patient underwent a spinal procedure on unknown levels in (b)(6) of 2019.As per reporter, patient began to experience pain and during a routine post-op follow up it was discovered there was a loose connector patient underwent a revision procedure on (b)(6) 2020.

• 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: 10138798
• Report Number: 2031966-2020-00123
• Device Sequence Number: 3361376
• Product Code: NKB
• UDI-Device Identifier: 00887517596246
• UDI-Public: 887517596246
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K132014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2020

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: 11104055
• 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: 05/12/2020
• Initial Report FDA Received Date: 06/10/2020
• 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