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

Catalog Number	MC1312P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an roi-c construct was installed too deep, then the plates and cage were damaged when being backed out of the disc space.There were no patient impacts.This is report two of two for this event.
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 3004788213-2022-00006.
Additional Manufacturer Narrative
Corrections in d4: udi number, d9, and h3.Additional information in d4: expiration date, h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: visual inspection revealed that the cage was fractured and the anchoring plates also have material deformation on the bottom side likely related to removal.Root cause: root cause was unable to be determined.It is possible that the space was not fully distracted, or the patient had hard bone causing difficulty placing the cage in the right place.Dhr review: per dhr reviews, the parts were likely conforming when they left zimvie control.Device usage: this device is 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.
Event or Problem Description
It was reported that an roi-c construct was installed too deep, then the plates and cage were damaged when being backed out of the disc space.There were no 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: 13333711
• Report Number: 3004788213-2022-00007
• Device Sequence Number: 1595599
• Product Code: OVE
• UDI-Device Identifier: 03662663016070
• UDI-Public: (01)03662663016070(17)240901(10)77876
• 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): 06/28/2022

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: 09/01/2024
• Device Catalogue Number: MC1312P
• Device Lot Number: 77876
• 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: 12/27/2021
• Supplement Date Received by Manufacturer: 06/17/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 06/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2019
• 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: Unknown
• Patient Weight: 79 KG