MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT ROI-C 14X15,5 H4,5; LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

Catalog Number MC1320P

Device Problems Malposition of Device (2616); Migration (4003)

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

Event Date 02/06/2023

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.

Event Description

It was reported that an roi-c cage was not well-positioned then it moved anteriorly and into the cortical rim of the vertebral body while the superior plate was being installed.The cage was removed and replaced to complete the procedure.There was a 10 minute delay and no impact to the patient.

Event Description

It was reported that an roi-c cage was not well-positioned then it moved anteriorly and into the cortical rim of the vertebral body while the superior plate was being installed.The cage was removed and replaced to complete the procedure.There was a 10 minute delay and no impact to the patient.

Manufacturer Narrative

Device evaluation: product was not returned and no photos were provided.Device evaluation unable to be performed.Root cause: root cause was unable to be determined.This event could possibly be attributed to improper placement initially or improper cage selection.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device usage: 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.

• Brand Name: IMPLANT ROI-C 14X15,5 H4,5
• Type of Device: LDR SPINE CERVICAL INTERBODY FUSION 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: 16484877
• MDR Text Key: 310861471
• Report Number: 3004788213-2023-00021
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 03662663016124
• UDI-Public: (01)03662663016124(17)270401(10)C92251
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K091088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC1320P
• Device Lot Number: C92251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2022
• 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