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

Model Number N/A

Device Problems Positioning Failure (1158); Mechanical Jam (2983)

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

Event Date 10/11/2017

Event Type  Injury  

Manufacturer Narrative

Complaint product can be one of the following products.Description don't allow to know which of them was wasted.Both device history records and traceability was reviewed and did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Ref : ir6002t / lot : 677870, expiration date : 01 sept 2021, device manufacture date : 10 oct 2016.Ref : ir6002t / lot : 682752, expiration date : 01 dec 2021, device manufacture date : 03 jan 2017.Device was discarded.

Event Description

Avenue l : anchoring plate wouldn't deploy and jammed.First cage was implanted without problem.For the second level, reporter warned surgeon not to implant the lower anchoring plate (conflict risk with other instrumentation).Surgeon still wanted to implant anchoring plate.Reporter told him to stop if he felt resistance.Surgeon felt resistance and stopped implanting.Surgeon had to retrieve cage and anchoring plate.The cage was then implanted again with only one upper anchoring plate.Removed anchoring plate discarded.

Manufacturer Narrative

Fields were updated for that medwatch report.Without a product return, no product evaluation is able to be conducted.As described by reporter, lower anchor shouldn't have been implanted because it would surly be in conflict with instrumentation already in place.The review tracaebility and 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.Surgeon was aware of the posterior fixation and as indicated into avenue-l surgical technique : "in case of posterior construct, it¿s imperative to verify the trajectory of the anchoring plate before implantation.If there is contact with additional hardware (posterior screws, steinman pins, etc.), do not force and it may be necessary to remove the half-anchoring plate." regarding information provided, root cause of this issue is related to an user error.The investigation found no evidence to indicate a device issue.

• Brand Name: AVENUE L ANCHORING PLATE M
• 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: loic richard ; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300 ; 3325823263
• MDR Report Key: 7012525
• MDR Text Key: 91414560
• Report Number: 3004788213-2017-00179
• 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

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IR6002T
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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