MAUDE Adverse Event Report: MEDTRONIC SOFAMOR DANEK, INC. CLYDESDALE SPINAL SYSTEM; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 2922250

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 05/05/2021

Event Type  malfunction  

Event Description

Neurosurgeon was placing implant at l4-5 when the cage broke.He used a long curette to try and extract the implant, and the tip broke off into the patient's disc space.The broken cage and tip of curette were removed from the patient with no obvious harm.

• Brand Name: CLYDESDALE SPINAL SYSTEM
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDTRONIC SOFAMOR DANEK, INC.; 1800 pyramid place; memphis TN 38132
• MDR Report Key: 11789590
• MDR Text Key: 249457577
• Report Number: 11789590
• Device Sequence Number: 1
• Product Code: MAX
• 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: 05/06/2021

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: 2922250
• Device Lot Number: 05EG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA