MAUDE Adverse Event Report: LDR MÉDICAL ROI-A MEDIAN IMPLANT PXL : 30X33 H 14MM 14; ROI-A ALIF CAGE SYSTEM

Model Number N/A

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/14/2021

Event Type  malfunction  

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 Description

It was reported that a roi-a cage cracked while the awl was being installed through the plate in surgery.The cage and awl were removed.Another cage was used to complete the procedure without reported patient impacts.

Manufacturer Narrative

Information added to h6: type of investigation, investigation findings, investigation conclusions.This follow-up report is being submitted to relay additional information.Summary.The complaint is unrefuted for the unreturned roi-a cag med h14mm 30x33mm 14 (pn: ir2641p) for the failure of cage fractured during operation.The cage was not returned and no photos were provided.Medical records were not provided for review.Potential cause since the product was not returned for evaluation, root cause can't be established.Dhr review and related actions per dhr review, the part was 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.A follow-up report will be submitted if new information is received that changes the information provided in this report.

Event Description

It was reported that a roi-a cage cracked while the awl was being installed through the plate in surgery.The cage and awl were removed.Another cage was used to complete the procedure without reported patient impacts.

• Brand Name: ROI-A MEDIAN IMPLANT PXL : 30X33 H 14MM 14
• Type of Device: 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: 11303547
• MDR Text Key: 233272809
• Report Number: 3004788213-2021-00011
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K153495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IR2641P
• Device Lot Number: M53770
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1