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 Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2017

Event Type  Injury  

Manufacturer Narrative

No information about return of device.

Event Description

Avenue t : failure to implant.No other information about this case.First information was received by complaint team on 26 oct 2017.Additional information was requested 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.

Manufacturer Narrative

Fields were updated for this report.The product was not returned to the manufacturer.No evaluation can be made.The review of the device records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to reported event.Regarding data investigation and provided information, the root cause of this issue is unknown because it is the first time there is an issue with avenue t anchoring plate insertion regarding sclerotic bone and because there is no information which allow to check what the surgeon reported (sale rep was not present during the surgery and no x-rays are available).Other cause due to user error might trigger anchoring plate deterioration (angulation between implant holder and implant during insertion or anchoring plate loader not properly load on implant holder for example).Based on information available and on the investigation, the exact root cause of this issue can not be determined but we continue to track and trend this type of issue.Moreover it can be mentioned that surgeon made an "off label¿ use of the product.Indeed, it was the surgeon choice not to implant the second half anchoring plate and he did not implant posterior fixation system.So surgeon did not follow indications in the ifu.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.

Event Description

Avenue t : implanted only one half anchoring plate in cage due to sclerotic bone.Additional information received on 02/jan/2018, 20/jan/2018 and 29/jan/2018 from discussion between sale representative and surgeon shows that during the operation the surgeon was not able to insert the first anchoring plate (anchoring plate deterioration).So he asked for new anchoring plate (from the same lot) and made the choice to insert only one half anchoring plate into the vertebral plate.He justified his choice by the sclerotic condition of the patient bone.The second half anchoring plate was not inserted.Surgeon confirms that the implant was not defective.No posterior fixation system was implanted.No impact on patient.

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.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.Additional information requested.

Event Description

Avenue t : failure to implant update on 06 dec 2017 : when they opened the packaging, implant appeared to be defectly, surgeon chooses another implant (same lot#) so no impact on patient because issue detected at packaging opening.Additional information requested.

• 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: loïc richard ; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300 ; 3325823263
• MDR Report Key: 6982762
• MDR Text Key: 90390300
• Report Number: 3004788213-2017-00165
• 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,Followup,Followup
• Report Date: 01/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: N/A
• Device Catalogue Number: AT0008T
• Device Lot Number: 667681
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/19/2016
• 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