MAUDE Adverse Event Report: LDR MÉDICAL AVENUE L CAGE H12MM 17X40MM 10; INTERVERTEBRAL BODY FUSION DEVICE

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 10/11/2017

Event Type  malfunction  

Manufacturer Narrative

Device implanted.

Event Description

Avenue l : cage retrieved and re-implanted.First cage was implanted without problem.For the second level, surgeon had to retrieve cage and anchoring plate.(problem also investigated in the complaint, reported separately).The cage was then implanted again.As defined in ifu avenue-l, "under no circumstances may the implants be re-used".Investigation is in progress on this event.The review of the device history records and traceability for the devices did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.

Manufacturer Narrative

Regarding the re-implantation of the cage, as defined in ifu avenue-l, "under no circumstances may the implants be re-used".As case of two-level not communicate to be consequently procured, there was only one cage of this size available, cage was checked and implanted with a new anchoring plate.The review of the device history records and traceability for the device did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Regarding information provided, root cause of this issue is related to an user error as re-implantation of a cage is off-label.The investigation found no evidence to indicate a device issue.

• Brand Name: AVENUE L CAGE H12MM 17X40MM 10
• 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 ; 3325823263
• MDR Report Key: 7013804
• MDR Text Key: 92738330
• Report Number: 3004788213-2017-00186
• 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
• Report Date: 01/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: IR6252P
• Device Lot Number: 52854
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 10/11/2017
• Supplement Dates FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/17/2016
• 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
• Patient Age: 38 YR