MAUDE Adverse Event Report: NUVASIVE NUVASIVE RELINE SCREW AND ROD FIXATION SYSTEM 5.5; SPINAL SYSTEM

Device Problems Break (1069); Mechanics Altered (2984)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/02/2016

Event Type  malfunction  

Event Description

During routine posterior lumbar fusion l4-5 a final lockdown of the set screws for the inserted 4 pedicle screws is required using a torque wrench screw driver.The first 3 screws locked down without difficulties, in the final one the screwdriver broke off in the set screw.Efforts at either removing the broken screw driver tip from the set screw or to remove the while set screw were unsuccessful, requiring us to cut the rod, removing the screw assembly and exchanging the affected screw and then implanting a new rod.The pt was not harmed, but the surgery took about 60 minutes longer than expected.The defective screw driver and screw assembly was sent to the pathology department for identification and evaluation.Diagnosis or reason for use: l4-5 spondylolisthesis.

• Brand Name: NUVASIVE RELINE SCREW AND ROD FIXATION SYSTEM 5.5
• Type of Device: SPINAL SYSTEM
• Manufacturer (Section D): NUVASIVE; sand diego CA
• MDR Report Key: 5781763
• MDR Text Key: 49255471
• Report Number: MW5063316
• Device Sequence Number: 1
• Product Code: NKB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 61