MAUDE Adverse Event Report: SPINEOLOGY, INC.; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Model Number 303-0069

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/14/2021

Event Type  malfunction  

Event Description

The tip of the straight curette by spineology broke off into the spine of the patient.Surgeon retrieved the broken piece under x-ray guidance.No pieces left in patient.

• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): SPINEOLOGY, INC.; 7800 3rd street n suite 600; saint paul MN 55128
• MDR Report Key: 11699480
• MDR Text Key: 246553433
• Report Number: 11699480
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 303-0069
• Device Catalogue Number: 303-0069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1