MAUDE Adverse Event Report: LDR MEDICAL ROI-A ANCHORING PLATE M; ROI-A ALIF CAGE SYSTEM

Catalog Number	IR2008T
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
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 the second anchoring plate of an roi-a construct could not be installed because the patient had hard bone and an awl was not available to create the pilot hole for the plate.There were no patient impacts reported, but the surgeon was not satisfied with the construct.
Additional Manufacturer Narrative
H6: additional method code: 4109.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: the device was not returned, so an evaluation is unable to be performed.An x-ray was provided which shows that only one of the anchoring plates is installed.Root cause: a definitive root cause cannot be determined with the information provided.The awl not being available and the patient's hard bone may have contributed to this issue.Dhr review: per dhr review, the part was likely conforming when it left zimvie 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 second anchoring plate of an roi-a construct could not be installed because the patient had hard bone and an awl was not available to create the pilot hole for the plate.There were no patient impacts reported, but the surgeon was not satisfied with the construct.

• Brand Name: ROI-A ANCHORING PLATE M
• 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: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 18301728
• Report Number: 3004788213-2023-00140
• Device Sequence Number: 7152129
• Product Code: MAX
• UDI-Device Identifier: 03662663010986
• UDI-Public: (01)03662663010986(17)280201(10)290439/5
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

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: IR2008T
• Device Lot Number: 290439/5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/16/2023
• 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
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic