MAUDE Adverse Event Report: LDR MÉDICAL ROI-C IMPLANT 14 MM X 14 MM H8 MM; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1314P
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Discomfort (2330); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
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 reports through 3004788213-2022-00057.
Event or Problem Description
It was reported that during surgery, the surgeon felt there was a difference between the height of two different roi-c trial footprints, so elected to place a 1 mm taller cage.Then immediately post-operatively, the patient felt unwell, had difficulty breathing, and heavy bleeding.The patient was returned to the or where the cage was removed, the area and clot were cleaned out, and a new cage was installed so the patient was out of danger.This is report one of three for this event.
Event or Problem Description
It was reported that during surgery, the surgeon felt there was a difference between the height of two different roi-c trial footprints, so elected to place a 1mm taller cage.Then immediately post-operatively, the patient felt unwell, had difficulty breathing, and heavy bleeding.The patient was returned to the or where the cage was removed, the area and clot were cleaned out, and a new cage was installed so the patient was out of danger.This is report one of three for this event.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device (mc1314p) matches the information in the complaint file and was examined.Visual inspection revealed that the cage was fractured.The fracture may have occurred during the revision surgery since it is not mentioned in the complaint description.Potential cause: root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles for the trials.Dhr review: per dhr review, the parts were likely conforming when they 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.

• Brand Name: ROI-C IMPLANT 14 MM X 14 MM H8 MM
• 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: 15146841
• Report Number: 3004788213-2022-00055
• Device Sequence Number: 12224702
• Product Code: OVE
• UDI-Device Identifier: 03662663016094
• UDI-Public: (01)03662663016094(17)241001(10)75169
• 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: 2022
• Device Explanted Year: 2022
• 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): 12/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2024
• Device Catalogue Number: MC1314P
• Device Lot Number: 75169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 07/14/2022
• Supplement Date Received by Manufacturer: 12/01/2022
• Initial Report FDA Received Date: 08/02/2022
• Supplement Report FDA Received Date: 12/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 52 YR
• Patient Sex: Female
• Patient Weight: 60 KG