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

Catalog Number	IR2543P
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Numbness (2415)
Date of Event	10/22/2023
Type of Reportable Event	Serious Injury
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 threads of an roi-a cage inserter were damaged and would not attach to a cage.A second cage was opened to confirm the problem was with the threads of the inserter.Therefore, the surgeon decided to place the implant without the inserter.Then the cage discreetly receded when the anchoring plates were installed, causing a possible conflict on the nerve root in the foramen.The patient had numbness in her right leg the day after surgery which continued after her discharge from the hospital, but she did not lose motor function.There was a delay of about 45 minutes to the procedure.
Additional Manufacturer Narrative
H6 additional investigation type code: 4109.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: -the product was not returned and no photos were provided, however x-rays were provided and reviewed.Based on the x-rays and review of the roi-a surgical technique, the spacer position is too far posterior indicating that the reported event is confirmed.Potential root cause -this event is attributed to the surgeon implanting the spacer without the use of the inserter instrument.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 zimvie¿s control.Device usage: -this device is used for treatment.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 threads of an roi-a cage inserter were damaged and would not attach to a cage.A second cage was opened to confirm the problem was with the threads of the inserter.Therefore, the surgeon decided to place the implant without the inserter.Then the cage discreetly receded when the anchoring plates were installed, causing a possible conflict on the nerve root in the foramen.The patient had numbness in her right leg the day after surgery which continued after her discharge from the hospital, but she did not lose motor function.There was a delay of about 45 minutes to the procedure.

• Brand Name: ROI-A MEDIAN IMPLANT PXL : 27X30 H 14MM 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: sabrina abla ; 10225 westmoor dr.; westminster, CO 80021 ; 7206965158
• MDR Report Key: 18162106
• Report Number: 3004788213-2023-00127
• Device Sequence Number: 7322421
• Product Code: MAX
• UDI-Device Identifier: 03662663011433
• UDI-Public: (01)03662663011433(17)270701(10)L222852
• 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
• Device Implanted 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): 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: IR2543P
• Device Lot Number: L222852
• 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: 11/17/2023
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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: IMPLANT INSERTER: IR9280R-1 LOT 210172002/05
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic