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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Pain (1994); Pressure Sores (2326)

Event Date 08/09/2020

Event Type  Injury  

Manufacturer Narrative

The product was not returned for evaluation as no malfunction was alleged.No radiographs or images provided.Even though root cause of the alleged event cannot be confirmed, information received indicates patient related factors may have contributed to alleged event.Labeling review: ".Potential adverse events and complications potential risks identified with the use of this system, which may require additional surgery, include: pain, discomfort or abnormal sensations due to the presence of the device.".

Event Description

On (b)(6) 2019 a patient underwent a posterior fixation procedure at t12/sai levels.As per reporter, the implant was removed on (b)(6) 2020, due to a pressure sore around t12/l2 levels.It was reported that fusion was competed.

• Brand Name: NUVASIVE RELINE SYSTEM
• Type of Device: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer (Section G): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd.; san diego, CA 92121
• MDR Report Key: 10512632
• MDR Text Key: 206299696
• Report Number: 2031966-2020-00179
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K182974
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/12/2020
• 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): Hospitalization
• Patient Age: 81 YR