MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORDOTIC COATED IMPLANT 14X17 H7; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number CMC1433P

Device Problem Malposition of Device (2616)

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

Event Date 05/09/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation visual inspection revealed no signs of damage.Additionally, the plate is jammed in the cage.Potential cause root cause was unable to be determined.This event could possibly be attributed to inserting the plate off-axis.Dhr review per dhr review, the cage was likely conforming when it left zimvie control.Device use these devices are 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.Reference report 3004788213-2022-00080.

Event Description

It was reported an roi-c plate was misaligned in the cage during attempted installation intra-operatively.The cage and plate were removed and replaced with new implants to complete the procedure without patient impacts.The manufacturer found the device to be jammed together.This is report one of two for this event.

• Brand Name: ROI-C LORDOTIC COATED IMPLANT 14X17 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: 15597874
• MDR Text Key: 303553593
• Report Number: 3004788213-2022-00079
• Device Sequence Number: 1
• Product Code: OVE
• UDI-Device Identifier: 03662663023498
• UDI-Public: (01)03662663023498(17)240101(10)67925
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151934
• 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
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: CMC1433P
• Device Lot Number: 67925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2019
• 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