MAUDE Adverse Event Report: LDR MÉDICAL AVENUE T CAGE H11MM L30MM 9; INTERVERTEBRAL BODY FUSION DEVICE

Model Number N/A

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pain (1994)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

Product was received by manufacturer.Visual examination was performed.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.One of the two screws actually moved during the initial surgery.The surgeon felt it, but thought that adding the cage and the anchoring plate would allow the overall stability.The screw has not migrated, but seems not "hooked" during the revision.As a result, compression should not be very effective.The cage also seemed to move during the revision.No fusion or fibrosis present during the revision.During the revision, the surgeon did not use the anchoring plate avenue t unlocking system but managed to remove the 2 half-anchoring plates with the hook.Therefore, it is possible to say that these 2 half anchoring plates were probably not locked in the cage.Investigation found that root cause of this event is an use error during anchoring plate insertion.Causing conflict with the easyspine screw and preventing the proper locking of the 2 half anchoring plate.Indeed, during the binocular analysis of the half anchoring plate, marks were found on the tip of one half anchoring plate.The tip were twisted / blunted.As mentioned in the surgical technique ": if a posterior osteosynthesis system is inserted, anchoring plate insertion must be done with care to avoid any conflict between both constructs.Investigation found no evidence to a product issue.Root cause of the event : user error ( failure to follow instruction during plate insertion).

Event Description

Avenue-t : revision due to pain: revision surgery was performed (b)(6) 2018.Initial surgery was done one month ago.Revision due to pain reappeared 2 weeks after initial surgery.Ablation of 1 cage avenue t + 1 anchoring plate avenue t + 2 screws easyspine + 1 rod easyspine.Products were then replaced.(one report created for each product involved in the event).

• Brand Name: AVENUE T CAGE H11MM L30MM 9
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7446565
• MDR Text Key: 106033325
• Report Number: 3004788213-2018-00120
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PN/A
• 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: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: N/A
• Device Catalogue Number: AT0031P
• Device Lot Number: 50393
• Other Device ID Number: 010366266300169417211001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2016
• 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 Outcome(s): Required Intervention