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

Model Number 15455500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Seizures (2063); Reaction (2414)

Event Date 01/10/2018

Event Type  Injury  

Manufacturer Narrative

No product returned for evaluation as it remains in-situ, nor allegation of product malfunction.No revision procedure is planned at this time.Label review: ".Warnings, cautions and precautions: caution must be taken due to potential patient sensitivity to materials.Do not implant in patients with known or suspected sensitivity to the aforementioned materials." ".Contraindications: contraindications include but are not limited to: infection, local to the operative site, signs of local inflammation, patients with known sensitivity to the materials implanted.".

Event Description

Received information stating patient was experiencing severe allergic reactions post operative.Inquiry received, breakdown of the metals in each of the pieces utilized in the patient's procedure.

• 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: virnalisa cobacha ; 7475 lusk boulevard; san diego, CA 92121
• MDR Report Key: 9497776
• MDR Text Key: 183098482
• Report Number: 2031966-2019-00264
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517594204
• UDI-Public: 887517594204
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143684
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 15455500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 14 YR