MAUDE Adverse Event Report: LDR MÉDICAL ROI-A ANCHORING PLATE M; AVENUE L LATERAL LUMBAR CAGE, AVENUE T TLIF CAGE SYSTEM, ROI-A ALIF CAGE SYSTEM,

Catalog Number IR2008T

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2021

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference reports 3004788213-2021-00124 through 3004788213-2021-00127.

Event Description

It was reported that two roi-a cages broke intra-operatively when the surgeon was attempting to mallet the plates into place.The plates were difficult to install into the bone; the patient had hard, sclerotic bone.Both cages and the plates were removed and replaced with other cages and plates.The started awl was used to prepare the pathway for the final plates.There was a surgical delay, but no patient impacts.This is report two of four for this event.

Manufacturer Narrative

Device evaluation: product was not returned and photos were not provided.The provided x-rays do not show the impacted devices.The device evaluation cannot be completed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to hard bone or the plates being inserted off-axis.Dhr review: the dhr was unable to be reviewed since the lot number is unknown.Device use: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

Event Description

It was reported that two roi-a cages broke intra-operatively when the surgeon was attempting to mallet the plates into place.The plates were difficult to install into the bone; the patient had hard, sclerotic bone.Both cages and the plates were removed and replaced with other cages and plates.The started awl was used to prepare the pathway for the final plates.There was a surgical delay, but no patient impacts.This is report two of four for this event.

• Brand Name: ROI-A ANCHORING PLATE M
• Type of Device: AVENUE L LATERAL LUMBAR CAGE, AVENUE T TLIF CAGE SYSTEM, ROI-A ALIF CAGE SYSTEM,
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 12521797
• MDR Text Key: 273000817
• Report Number: 3004788213-2021-00125
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IR2008T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2022
• 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
• Patient Sequence Number: 1