MAUDE Adverse Event Report: LDR MÉDICAL AVENUE L ANCHORING PLATE S; INTERVERTEBRAL BODY FUSION DEVICE

Model Number N/A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 10/11/2017

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.More information were requested regarding retrieval of anchoring plates.Not returned to manufacturer.

Event Description

Avenue-l : failure to implant.Devices were implanted and removed.Surgery was completed by another medical device.

Manufacturer Narrative

New information received on 12 jan 2018 enabled to reassess the complaint.The description initially received was corrected by reporter.The issue was not related to serious injury, delay in surgery, nor device malfunction.It was only a mistake when opening boxes.Design, labelling or packaging of the product is not involved.No other report will be sent on this event.

Manufacturer Narrative

The following information was received by phone on 07 nov but was not mentioned in the initial medwatch : it was a two level implantation.Attempts have been made and no further information has been provided yet.Investigation is in progress.

Event Description

Avenue-l : failure to implant.

• Brand Name: AVENUE L ANCHORING PLATE S
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE
• 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: 7010042
• MDR Text Key: 91361321
• Report Number: 3004788213-2017-00183
• 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: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: N/A
• Device Catalogue Number: IR6001T
• Device Lot Number: 702566
• Other Device ID Number: N/A
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2017
• 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