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

Catalog Number	MC1312P
Medical Device Problem Codes	Fracture (1260); Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
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 3004788213-2021-00075.
Event or Problem 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.
Additional 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 or Problem 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
• 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, 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
• Report Number: 3004788213-2021-00076
• Device Sequence Number: 19927911
• Product Code: OVE
• UDI-Device Identifier: 03662663016070
• UDI-Public: (01)03662663016070(17)240701(10)73123
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2021

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 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 07/21/2021
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2019
• 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
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 60 KG