MAUDE Adverse Event Report: MEDOS INTERNATIONAL SÀRL CONCORDE; INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

Model Number 187823408

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/18/2020

Event Type  malfunction  

Event Description

The surgeon used a cage implant from depuy synthes (bullet cage).Cage broke when surgeon placed it in patient's spine, surgeon tried to take the rest of the fragments out but was not able to.The surgeon opted not to retrieve as the retained portion was seated within the intended space and removing may have caused more harm than leaving in the space.Manufacturer response for spinal cage, concorde interbody system (per site reporter).No response to date.

• Brand Name: CONCORDE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR
• Manufacturer (Section D): MEDOS INTERNATIONAL SÀRL; 325 paramount drive; raynham MA 02767
• MDR Report Key: 10648130
• MDR Text Key: 210424826
• Report Number: 10648130
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 187823408
• Device Catalogue Number: 187823408
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Weight: 66