MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORDOTIC COATED IMPLANT 12X14 H7; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Catalog Number	MC1443P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
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.
Event or Problem Description
It was reported that an roi-c cage fractured while being malleted into the disc space intra-operatively.The cage and fractured piece were recovered and a new cage was installed, leading to a delay of 10 minutes.There were no patient impacts.
Event or Problem Description
It was reported that an roi-c cage fractured while being malleted into the disc space intra-operatively.The cage and fractured piece were recovered and a new cage was installed, leading to a delay of 10 minutes.There were no patient impacts.
Additional Manufacturer Narrative
Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed that the cage was fractured.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.

• Brand Name: ROI-C LORDOTIC COATED IMPLANT 12X14 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: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 16925968
• Report Number: 3004788213-2023-00043
• Device Sequence Number: 7008202
• Product Code: OVE
• UDI-Device Identifier: 03662663016544
• UDI-Public: (01)03662663016544(17)260101(10)81425
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150765
• 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 Expiration Date: 01/01/2026
• Device Catalogue Number: MC1443P
• Device Lot Number: 81425
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/11/2023
• 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: 04/18/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/13/2023
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/05/2021
• 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 Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic