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

Model Number N/A

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation can 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.Regarding information provided, root cause is related to an user error : knurled knob was not in contact with handle.As indicated into avenue-l surgical technique : "if the knurled knob is not in contact with the handle and/or the push button is not up, turn the knob to finalize handle insertion.If the handle is still not correctly positioned, take it off and insert it again onto the cage holder/threaded rod assembly.The investigation found no evidence to indicate a device issue.Device not returned as discarded.

Event Description

Avenue-l : anchor didn't deploy.As reported by sales rep.During avenue-l surgery : "the cage was placed.The anchoring plate still had to be inserted.When placing the first anchoring plate, the locking screw(silver knob on the proximal end of the insert) was not completely locked.As a result, the half anchoring plate holder with the first plate could not be inserted sufficiently deep enough in the implant holder and locked the path for the second anchoring plate.We removed the plate easily and were able to bring in the first plate sufficiently and clear the way for the second plate.The reporter decided to open a new packet of anchoring plate (same ref and lot #).The surgery was then successfully completed.No patient impact.

• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7421173
• MDR Text Key: 105148938
• Report Number: 3004788213-2018-00104
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• 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: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2022
• Device Model Number: N/A
• Device Catalogue Number: IR6001T
• Device Lot Number: 713946
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/05/2017
• 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