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

Model Number 8801244

Device Problem Material Fragmentation (1261)

Patient Problem Failure of Implant (1924)

Event Date 07/05/2019

Event Type  malfunction  

Manufacturer Narrative

No radiographs or ct images provided to confirm the alleged event.A review of the post case torque handle calibration verification found the precept torque limiting handle provided for use in this procedure recorded no values above the maximum torque allowed.No root cause could be determined at this time.Device not returned at this time.

Event Description

On (b)(6) 2019 patient underwent a posterior spinal fusion procedure.As per reporter, when tightening the left side superior screw, the lock screw driver tip failed.The compressor final driver was utilized to finish the case.Post operative imaging revealed that the tip of the lock screw driver and compressor final driver remained inside the patient.A revision procedure to removed both driver tips was completed with no other reported issues.

• 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; 7475 lusk blvd; san diego CA 92121
• Manufacturer Contact: george panfili ; 7475 lusk blvd; san diego, CA 92121
• MDR Report Key: 8849185
• MDR Text Key: 153221017
• Report Number: 2031966-2019-00223
• Device Sequence Number: 1
• Product Code: NKB
• UDI-Device Identifier: 00887517351142
• UDI-Public: 887517351142
• Combination Product (y/n): N
• 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: 07/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8801244
• Device Lot Number: TU6486
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization