MAUDE Adverse Event Report: LDR MÉDICAL ROI-A MEDIAN IMPLANT PXL : 30X33 H 12MM 6; AVENUE L LATERAL LUMBAR CAGE, AVENUE T TLIF CAGE SYSTEM, ROI-A ALIF CAGE SYSTEM,

Catalog Number	IR2624P
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Pain (1994)
Date of Event	08/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).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 x-rays from a post-operative review found that an roi-a cage shifted position at the l4-5 level, and the vertebral endplate fractured.The cage was initially placed during an anterior procedure, but the position shift was found after a second procedure was performed approximately three weeks later to add a posterior construct.The patient had lower back pain, which led to the post-operative review.The current plan of treatment consists of bed-rest; a revision to correct the cage's position is not currently planned.
Additional Manufacturer Narrative
(b)(4).Reported event was confirmed via x-rays which showed non-fusion related to anterior placement and unintended movement device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was further reported that there will be no revision and that the patient has a mild backache after the second operation, which tends to be alleviated.The patient is still under follow-up observation.

• Brand Name: ROI-A MEDIAN IMPLANT PXL : 30X33 H 12MM 6
• Common Device Name: AVENUE L LATERAL LUMBAR CAGE, AVENUE T TLIF CAGE SYSTEM, ROI-A ALIF CAGE SYSTEM,
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 10757951
• Report Number: 3004788213-2020-00159
• Device Sequence Number: 1061401
• Product Code: MAX
• UDI-Device Identifier: 03662663011570
• UDI-Public: (01)03662663011570(17)230501(10)18-238677
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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 Expiration Date: 05/01/2023
• Device Catalogue Number: IR2624P
• Device Lot Number: 18-23867
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/29/2020
• Supplement Report FDA Received Date: 11/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 57 YR