MAUDE Adverse Event Report: LDR MÉDICAL ROI-A WIDE IMPLANT PXL : 27X36 H 14MM 14; ROI-A ALIF CAGE SYSTEM

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Summary: the complaint is confirmed for one (1) of one (1) returned roi-a cag med h14mm 27x36mm 14 (pn ir5243p) for the failure of implant fractured during operation.Visual inspection revealed the cage has 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 cage was being used or handled at the time of the damage.However, the patient hard bone 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 this devices are used for treatment.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 plate would not advance into the patient's bone.The surgeon removed the plate and attempted to use an awl to create a pathway for the plate, but the cage cracked.The cage was removed and a new cage was used to complete the procedure.There was no patient impact or delay of surgery reported.

• Brand Name: ROI-A WIDE IMPLANT PXL : 27X36 H 14MM 14
• 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: 11855802
• Report Number: 3004788213-2021-00056
• Device Sequence Number: 3854291
• Product Code: MAX
• UDI-Device Identifier: 03662663013802
• UDI-Public: (01)03662663013802(17)250101(10)L190308
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/20/2021

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: 01/01/2025
• Device Model Number: N/A
• Device Catalogue Number: IR5243P
• Device Lot Number: L190308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 05/20/2021
• 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
• Patient Weight: 49