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

Model Number 9392508

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/23/2017

Event Type  malfunction  

Event Description

The doctor was inserting a transforaminal lumbar interbody fusion (tlif) cage into l5-s1 level.The cage was attached to the inserter and while being pushed into place, the cage broke.

• Brand Name: CRESCENT¿ 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: 6989892
• MDR Text Key: 90689627
• Report Number: 6989892
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/24/2017

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: Physician
• Device Expiration Date: 07/12/2019
• Device Model Number: 9392508
• Device Catalogue Number: 9392508
• Device Lot Number: H11E3142
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/24/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR