MAUDE Adverse Event Report: LDR MÉDICAL ROI-A WIDE IMPLANT PXL : 30X39 H 12MM 10; ROI-A ALIF CAGE SYSTEM

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2021
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 cage fractured during surgery while being removed with the plate after there were difficulties installing the mating plate in surgery.The cage was removed and replaced with an alternative device to complete the procedure.There were no patient impacts.
Additional Manufacturer Narrative
Information added to h6: component codes, type of investigation, investigation findings, investigation conclusions corrected information in h3 this follow-up report is being submitted to relay additional information and initially corrected information.Summary the complaint is confirmed for returned roi-a cage (pn: ir5332p) for the failure of cages fractured.Visual inspection of the device reveals the cage is fractured.Medical records were not provided for review.Potential cause the cause of the damage cannot be determined at this time since there is no information available regarding how the implants were being used or handled at the time of the damage.However, the patient has sclerotic bone which could have contributed to this event.Dhr review and related actions per dhrs review, the parts were likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.Device use and compatibility this devices are used for treatment.Reported event is not related to a combination of product lines; therefore a compatibility review is not applicable.A follow-up report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
It was reported that a cage fractured during surgery while being removed with the plate after there were difficulties installing the mating plate in surgery.The cage was removed and replaced with an alternative device to complete the procedure.There were no patient impacts.

• Brand Name: ROI-A WIDE IMPLANT PXL : 30X39 H 12MM 10
• Common Device Name: ROI-A ALIF CAGE SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, n/a 10300 ; FR 10300
• MDR Report Key: 11367196
• Report Number: 3004788213-2021-00016
• Device Sequence Number: 19498240
• Product Code: MAX
• UDI-Device Identifier: 03662663014168
• UDI-Public: (01)03662663014168(17)240301(10)18-296385
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K153495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2021

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 Expiration Date: 03/01/2024
• Device Model Number: N/A
• Device Catalogue Number: IR5332P
• Device Lot Number: 18-296385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ANCHORING PLATE, IR2009T, 779332.
• Patient Age: 36 YR