MAUDE Adverse Event Report: LDR MÉDICAL ROI-C IMPLANT 14X14 H7; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number MC1312P

Device Problems Fracture (1260); Malposition of Device (2616)

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

Event Date 06/23/2021

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 report 3004788213-2021-00075.

Event Description

It was reported that while inserting a plate through the cage, the plate became stuck and could not be advanced or removed.The cage was broken to remove the plate.The cage was also removed and both pieces were replaced with competitive product to complete the procedure without patient impacts.This is report two of two for this event.

Manufacturer Narrative

Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned for evaluation.However, photos provided by the reporter confirm the device had fractured.Potential cause a definitive root cause cannot be determined with the information provided.It could be attributed to the cage being wrongly positioned.Dhr review per dhr review, the parts were likely conforming when they left zimmer biomet control.Device use these devices are used for treatment.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that while inserting a plate through the cage, the plate became stuck and could not be advanced or removed.The cage was broken to remove the plate.The cage was also removed and both pieces were replaced with competitive product to complete the procedure without patient impacts.This is report two of two for this event.

• Brand Name: ROI-C IMPLANT 14X14 H7
• Type of Device: ROI-C TITANIUM-COATED IMPLANT 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: 12203139
• MDR Text Key: 262667576
• Report Number: 3004788213-2021-00076
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 03662663016070
• UDI-Public: (01)03662663016070(17)240701(10)73123
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151934
• 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: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC1312P
• Device Lot Number: 73123
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2019
• 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
• Patient Sex: Male
• Patient Weight: 60 KG