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

Model Number 11104055

Device Problem Disconnection (1171)

Patient Problem Failure of Implant (1924)

Event Date 05/11/2020

Event Type  malfunction  

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 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
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INCORPORATED; 7475 lusk boulevard; san diego CA 92121
• Manufacturer Contact: dean lucas ; 7474 lusk boulevard; san diego, CA 92121
• MDR Report Key: 10138798
• MDR Text Key: 194945125
• Report Number: 2031966-2020-00123
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517596246
• UDI-Public: 887517596246
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11104055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/12/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization