MAUDE Adverse Event Report: LDR MEDICAL ROI-C IMPLANT 14X17 H7; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1332P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an roi-c cage broke apart during insertion intra-operatively.It was removed and replaced with a different implant to complete the procedure.There was a delay of 5 minutes, but there were no impacts to the patient.
Additional Manufacturer Narrative
D10: mc1632 (bone substitute roi-c 14x17 h6) lot unknown, mc1005t (roi-c anchoring plate) lot unknown.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.
Additional Manufacturer Narrative
Corrections in g1.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned and no photos were provided, so an evaluation is unable to be performed.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to excessive forces applied during insertion.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 cage broke apart during insertion intra-operatively.It was removed and replaced with a different implant to complete the procedure.There was a delay of 5 minutes, but there were no impacts to the patient.
Additional Manufacturer Narrative
Inspection the returned device matches the information in the complaint file and was examined.Visual inspection revealed the cage has fractured.See attached images.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¿s control.Potential root cause a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to excessive forces applied during insertion.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 cage broke apart during insertion intra-operatively.It was removed and replaced with a different implant to complete the procedure.There was a delay of 5 minutes, but there were no impacts to the patient.

• Brand Name: ROI-C IMPLANT 14X17 H7
• Common Device Name: ROI-C TITANIUM-COATED IMPLANT SYSTEM
• Manufacturer (Section D): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MEDICAL; 5 rue de berlin; quartier europe de l'ouest; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: teresa george ; 10225 westmoor dr.; westminster, CO 80021 ; 3035018506
• MDR Report Key: 19093375
• Report Number: 3004788213-2024-00033
• Device Sequence Number: 18067045
• Product Code: OVE
• UDI-Device Identifier: 03662663016216
• UDI-Public: (01)03662663016216(17)280301(10)C96068
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/10/2024

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: Health Professional
• Device Catalogue Number: MC1332P
• Device Lot Number: C96068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 09/16/2024; 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic