MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE PRECEPT SPINAL SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

Model Number 8847070006

Device Problem Detachment Of Device Component (1104)

Patient Problem Failure of Implant (1924)

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

A review of the x-ray confirms the detachment form the screw.No product has been returned for evaluation therefore root cause cannot has not been identified.Labeling review: ".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: bending, fracture or loosening of implant component(s).".

Event Description

On (b)(6) 2017 a patient underwent transforaminal lumbar interbody fusion procedure at the l3-l5 levels.On june 12, 2017 x-rays showed the cranial end of the rod had detached from the screw.On (b)(6) 2017 a revision surgery was performed to replace the rod and set screw.No patient injury was reported.

• Brand Name: NUVASIVE PRECEPT SPINAL 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: yobana sanchez ; 7475 lusk blvd; san diego, CA 92121 ; 8589093383
• MDR Report Key: 6690248
• MDR Text Key: 79178059
• Report Number: 2031966-2017-00087
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K122352
• 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: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8847070006
• Device Lot Number: CT42030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2017
• Initial Date FDA Received: 07/06/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/06/2016
• 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