MAUDE Adverse Event Report: LDR MÉDICAL ROI-A ANCHORING PLATE; INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT

Model Number N/A

Device Problems Break (1069); Difficult to Insert (1316)

Patient Problems Failure of Implant (1924); No Information (3190)

Event Date 09/21/2018

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the an initial report.There is a lot of information missing about the incident and different means of communication are in place in order to know more details about the incident.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.Investigation still is progress.Not returned.

Event Description

Roi-a : cage broken during surgery an incident occured in the hospital of (b)(6).During a roi-a surgery, at l4-l5, the anchoring plate was really difficult to insert in l5, the cage was then broken and the implant holder disassembled from the cage.Anchoring plate was removed in l5.Another anchoring plate was implanted in l4.No other information is provided.A request to fill out a complaint form was refused.Other means of communication are in progress in order to get more information.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint following the project manager analysis received.The product was not returned to the manufacturer.The product location is unknown.Therefore, no product evaluation could be 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.From the information provided, the product history records, the review of the case with the product manager, the recurrence of this type of event for this product, the investigation found the cause is a user error.The project manager reported that a white mass at the instrumented segment can be observed on the provided x-ray image.This white mass in l5 represents a different density, which is characterized by a very hard bone.It is clearly stated in the surgical technique that in normal bone structure, the insertion of the half anchoring plate is a simple and effortless step.Nevertheless in order to prepare the anchoring plate trajectory, the starter awl is recommended for each roi-a surgery.The use of the starter awl is up to the surgeon based on his surgical and product knowledge, pre-operative assessment of the patient¿s case and pre-operative signs of bone density on the instrumented level(s).Yet, in the sales order of the surgery received, the roi-a sterile starter awl for anchoring plate (reference (b)(4)) was not invoiced, meaning that it was not used during the surgery.Many attempts to the sales representatives, the customer service or the materiovigilance reporter of the hospital were made to collect additional information on the reported event.Yet, no additional information was received.Based on the available information, the reported event is related to patient hard bone and absence of sterile starter awl use as recommended by the surgical technique.The investigation found no evidence to indicate a device related issue.If additional information is received that is in conflict with this analysis, this case will be reopened and the root cause of the complaint will be reevaluated.Device not returned.

Event Description

Roi-a: cage broken during surgery.An incident occured in the hospital of (b)(6).During a roi-a surgery, at l4-l5, the anchoring plate was really difficult to insert in l5, the cage was then broken and the implant holder disassembled from the cage.Anchoring plate was removed in l5.Another anchoring plate was implanted in l4.No other information is provided.A request to fill out a complaint form was refused.

• Brand Name: ROI-A ANCHORING PLATE
• Type of Device: INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7998896
• MDR Text Key: 124806084
• Report Number: 3004788213-2018-00349
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2023
• Device Model Number: N/A
• Device Catalogue Number: IR2008T
• Device Lot Number: 740741
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 65 YR