MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORDOTIC COATED IMPLANT 12 X14 H6; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional 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 3004788213-2021-00017.
Event or Problem Description
It was reported that an anchoring plate became stuck during insertion into a cage.The surgeon removed the stuck anchoring plate and cage.The surgery was completed using a new cage and the other original anchoring plate that was not stuck.There was no reported impact to the patient.This is report two of two for this event.
Event or Problem Description
It was reported that an anchoring plate became stuck during insertion into a cage.The surgeon removed the stuck anchoring plate and cage.The surgery was completed using a new cage and the other original anchoring plate that was not stuck.There was no reported impact to the patient.This is report two of two for this event.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned.One photo was provided, however the detail of the photo does not allow for device evaluation.The complaint is unrefuted.Potential cause: root cause was unable to be determined.This event could possibly be attributed to misaligning the plate.Dhr review: per dhr review, the part was likely conforming when it left zimmer biomet control.Device use for treatment.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 or Problem Description
It was reported that an anchoring plate became stuck during insertion into a cage.The surgeon removed the stuck anchoring plate and cage.The surgery was completed using a new cage and the other original anchoring plate that was not stuck.There was no reported impact to the patient.This is report two of two for this event.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: investigation type.Device evaluation: the returned cage was examined and found to be deformed due to binding with the plate.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: ROI-C LORDOTIC COATED IMPLANT 12 X14 H6
• Common Device Name: ROI-C TITANIUM-COATED IMPLANT SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, n/a 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.; n/a; westminster, CO 80021 ; 3035144809
• MDR Report Key: 11372171
• Report Number: 3004788213-2021-00018
• Device Sequence Number: 17153261
• Product Code: OVE
• UDI-Device Identifier: 03662663023542
• UDI-Public: (01)03662663023542(17)240701(10)73211
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/01/2024
• Device Model Number: N/A
• Device Catalogue Number: CMC1442P
• Device Lot Number: 73211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 07/20/2021; 05/27/2022
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 07/22/2021; 06/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Sex: Male