MAUDE Adverse Event Report: SPINAL SIMPLICITY LLC MINUTEMAN G3R; SPINOUS PROCESS PLATE

Model Number 10-0019-000

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/17/2021

Event Type  Injury  

Event Description

During implantation the insertion device and/ or implant broke.Fda safety report id# (b)(4).

• Brand Name: MINUTEMAN G3R
• Type of Device: SPINOUS PROCESS PLATE
• Manufacturer (Section D): SPINAL SIMPLICITY LLC; overland park KS 66211
• MDR Report Key: 12365861
• MDR Text Key: 268313513
• Report Number: MW5103491
• Device Sequence Number: 1
• Product Code: PEK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 08/23/2021

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: Health Professional
• Device Model Number: 10-0019-000
• Device Lot Number: M44664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/24/2021
• 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
• Patient Age: 69 YR