MAUDE Adverse Event Report: LDR MÉDICAL AVENUE T ANCHORING PLATE M; INTERVERTEBRAL BODY FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Information (3190)

Event Date 10/20/2017

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.Three attempts have been made and no further information has been provided.Root cause is unknown.No information about device return.

Event Description

Avenue t : anchor wouldn't deploy.Three attempts have been made and no further information has been provided.Root cause is unknown.

• Brand Name: AVENUE T ANCHORING PLATE M
• 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
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: florence chapaud ; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300 ; 3310648075
• MDR Report Key: 7045354
• MDR Text Key: 92515661
• Report Number: 3004788213-2017-00195
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: N/A
• Device Catalogue Number: AT0008T
• Device Lot Number: 674560
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/09/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1