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

Catalog Number	MC1005T
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cranial plate of an roi-c construct was found broken at the one year post-operative follow-up.The patient is asymptomatic and is happy with the results, so the surgeon is not planning a revision to remove or replace the plate.
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation the product was not returned, so an evaluation was unable to be performed.The complaint is confirmed based on the provided x-ray where the anchoring plate is seen to be broken.Potential root cause a definitive root cause cannot be determined with the information provided.This even could possibly be attributed to excess forces seen postoperatively.Dhr review the lot number was not provided, so the dhr was unable to be reviewed.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 the cranial plate of an roi-c construct was found broken at the one year post-operative follow-up.The patient is asymptomatic and is happy with the results, so the surgeon is not planning a revision to remove or replace the plate.
Additional Manufacturer Narrative
Additional information in a2; a3; d4: lot number, expiration date, and udi number; and h4.A follow-up report will be sent if additional information is obtained that adds value to the relevant content of this report.
Event or Problem Description
It was reported that the cranial plate of an roi-c construct was found broken at the one year post-operative follow-up.The patient is asymptomatic and is happy with the results, so the surgeon is not planning a revision to remove or replace the plate.
Additional Manufacturer Narrative
H6: additional method code: 4109.Device evaluation: the device was not returned, however an x-ray image was provided which shows that the plate has fractured.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to unknown surgical or patient factors.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 the cranial plate of an roi-c construct was found broken at the one year post-operative follow-up.The patient is asymptomatic and is happy with the results, so the surgeon is not planning a revision to remove or replace the plate.

• 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: 15475617
• Report Number: 3004788213-2022-00071
• Device Sequence Number: 20334774
• Product Code: OVE
• UDI-Device Identifier: 03662663016971
• UDI-Public: (01)03662663016971(17)260201(10)821329
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K151934
• Exemption Number: 5645646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup,Followup
• Report Date (Section B): 07/09/2024

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 Expiration Date: 01/31/2026
• Device Catalogue Number: MC1005T
• Device Lot Number: 821329
• 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: 09/02/2022
• Supplement Date Received by Manufacturer: 12/08/2022; 12/08/2022; Not provided
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 12/09/2022; 11/10/2023; 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2021
• 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 Age: 37 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic