MAUDE Adverse Event Report: LDR MÉDICAL ROI-C ANCHORING PLATE; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1005T
Medical Device Problem Codes	Difficult to Insert (1316); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference report 3004788213-2023-00032.
Event or Problem Description
It was reported that an roi-c plate was difficult to install then bent and a cage broke intra-operatively.They were both removed and replaced to complete the procedure without patient impacts.This is report one of two for this event.
Additional Manufacturer Narrative
Corrections in d4: udi number, g1, and h3.Additional information in d4: expiration date, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed the plate is bent and has gouge marks.Root cause: a definitive root cause cannot be determined with the information provided.Dhr review: the dhr was reviewed.There are no indications of manufacturing issues which would have contributed to this event and the device was likely conforming when it left highridge medical¿s 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 plate was difficult to install then bent and a cage broke intra-operatively.They were both removed and replaced to complete the procedure without patient impacts.This is report one of two for this event.

• Brand Name: ROI-C ANCHORING PLATE
• 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: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16746660
• Report Number: 3004788213-2023-00031
• Device Sequence Number: 3276931
• Product Code: OVE
• UDI-Device Identifier: 03662663016971
• UDI-Public: (01)03662663016971(17)270401(10)289686/5
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151934
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2024

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: Other
• Device Catalogue Number: MC1005T
• Device Lot Number: 289686/5
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/04/2023
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2023
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic