MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE BRIGADE PLATE SCREW 5.5X32.5MM; APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Model Number 7805532

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/18/2021

Event Type  Injury  

Event Description

Intraoperatively, the brigade plate screw 5.5 x 32.5mm (sn# (b)(4)) was placed and during placement, the screw head broke off.Surgeon was unable to remove the screw, so remaining piece was left in place.Fda safety report id# (b)(4).

• Brand Name: NUVASIVE BRIGADE PLATE SCREW 5.5X32.5MM
• Type of Device: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
• Manufacturer (Section D): NUVASIVE, INC. ; san diego CA 92121
• MDR Report Key: 12432631
• MDR Text Key: 270312618
• Report Number: MW5103730
• Device Sequence Number: 1
• Product Code: KWQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7805532
• Device Catalogue Number: 7805532
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention