MAUDE Adverse Event Report: LDR MÉDICAL AVENUE T CAGE H8MM L30MM 0; INTERVERTEBRAL BODY FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number N/A

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Failure of Implant (1924)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

Associated devices: anchoring plate-m, at0008t lot number 672312, device mfr date: 2016-12-28, expiry date: 2021-11-01, no information provided regarding plates despite relaunches.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 regarding data investigation and provided information, the root cause of this issue is determined to be due to user error.There is no evidence to indicate a device issue.Discarded by hospital.

Event Description

Surgeon has screwed too much the implant on implant holder which damaged the threading.Implant wouldn't hold on implant holder anymore.Other implant and anchoring plates were opened.Implant discarded.

• Brand Name: AVENUE T CAGE H8MM L30MM 0
• 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: 7027527
• MDR Text Key: 91899315
• Report Number: 3004788213-2017-00190
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2021
• Device Model Number: N/A
• Device Catalogue Number: AT0012P
• Device Lot Number: 55196
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1