MAUDE Adverse Event Report: LDR MEDICAL ROI-A MEDIAN IMPLANT PXL : 27X30 H 12MM 14 DEG.; ROI-A ALIF CAGE SYSTEM

Catalog Number	IR2541P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that a roi-a cage and a roi-a anchor plate fractured intra-operatively.There was no reported patient impact; however, there was a 30 minute delay to the procedure.This is report one of two for this event.
Additional Manufacturer Narrative
H6: additional method code: 4109.Corrections in d9, g1, and h3.Additional information in 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 implant has fractured.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces applied to the anchoring plate 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.Reference report 3004788213-2024-00035.
Event or Problem Description
It was reported that a roi-a cage and a roi-a anchor plate fractured intra-operatively.There was no reported patient impact; however, there was a 30 minute delay to the procedure.This is report one of two for this event.

• Brand Name: ROI-A MEDIAN IMPLANT PXL : 27X30 H 12MM 14 DEG.
• Common Device Name: ROI-A ALIF CAGE 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: 19183238
• Report Number: 3004788213-2024-00034
• Device Sequence Number: 6989289
• Product Code: MAX
• UDI-Device Identifier: 03662663011419
• UDI-Public: (01)03662663011419(17)261201(10)L212204
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K153495
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2024

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: IR2541P
• Device Lot Number: L212204
• 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
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2021
• 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: (B)(4)., LOT 0281253305
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic