MAUDE Adverse Event Report: LDR MÉDICAL AVENUE T CAGE H10MM L30MM 5; INTERVERTEBRAL BODY FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number N/A

Device Problems Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Information (3190)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.No information about device return.

Event Description

Avenue-t : size issue.After using paddle distractors (used to choose device size), surgeon tried to implant the corresponding cage but he couldn't.He had to choose a cage with a smaller height.Attempts have been made and no further information has been provided yet.

Manufacturer Narrative

Product was never received by manufacturer.No examination could be performed.The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Several attempts were made to collect information about the event; no answer were received.Evaluation of provided information and the review of the device dhr and traceability shows that probable root cause is related to an incorrect choice of implant size.Investigation found no evidence on a product issue.If additional information were received that add value to this investigation or impact the conclusion, another report will be sent.

• Brand Name: AVENUE T CAGE H10MM L30MM 5
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7281620
• MDR Text Key: 100412566
• Report Number: 3004788213-2018-00036
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: N/A
• Device Catalogue Number: AT0021P
• Device Lot Number: 55207
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1