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

Model Number M18491 SIZE 10

Device Problems Defective Device (2588); Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

Event Date 04/04/2023

Event Type  malfunction  

Event Description

Provider removed implant and stated it had a device failure.

• Brand Name: MINUTEMAN G3R INTERSPINOUS DEVICE
• Type of Device: SPINOUS PROCESS PLATE
• Manufacturer (Section D): SPINAL SIMPLICITY, LLC
• MDR Report Key: 16707249
• MDR Text Key: 313059510
• Report Number: MW5116484
• Device Sequence Number: 1
• Product Code: PEK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/06/2023

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: M18491 SIZE 10
• Device Catalogue Number: 10-0101-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 81 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White