MAUDE Adverse Event Report: NUVASIVE INC. NUVASIVE POLYAXIAL SPINAL SCREWS; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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

Patient Problem Infection, Pyrogenic (2246)

Event Date 04/22/2019

Event Type  Injury  

Manufacturer Narrative

No product has been returned for evaluation as no product malfunction has been alleged.No radiographs or lab reports provided.All nuvasive devices utilized in this procedure were prepped and sterilized prior to the case by the end user facility and decontamination/sterilization records were not provided.Labeling review: ".Preoperative warnings 4.All non-sterile parts should be cleaned and sterilized before use." ".Compatibility: do not use the precept spinal system with components of other systems.Unless stated otherwise, nuvasive devices are not to be combined with the components of another system." ".Potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include: early or late infection." no product malfunction alleged.

Event Description

Information received stated on (b)(6) 2019, patient underwent a revision procedure due to pyogenic spondylitis where, precept screws of l2 were removed and precept reduction screws were added at th11, th12 and l1 levels.

• Brand Name: NUVASIVE POLYAXIAL SPINAL SCREWS
• 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: 10171095
• MDR Text Key: 195724294
• Report Number: 2031966-2020-00129
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K121619
• 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: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• 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: 12/16/2019
• 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 Age: 81 YR