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 Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/21/2021

Event Type  malfunction  

Manufacturer Narrative

Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.

Event Description

It was reported that when trying to impact an anchoring plate, the implant holder became disengaged from the implant and it was impossible to reposition the implant holder on the cage.The cage fractured.There was no reported patient impact.

Manufacturer Narrative

Inspection: the returned item was evaluated.Visual inspection reveals that the cage is fractured.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 zimmer biomet¿s control.Potential root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis or excessive forces applied during use.Device usage this device is used for treatment.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 when trying to impact an anchoring plate, the implant holder became disengaged from the implant and it was impossible to reposition the implant holder on the cage.The cage fractured.There was no reported patient impact.

• 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: 11842153
• MDR Text Key: 251210098
• Report Number: 3004788213-2021-00051
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 03662663011723
• UDI-Public: (01)03662663011723(17)240901(10)19-327221
• Combination Product (y/n): N
• PMA/PMN Number: K153495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• 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: 19-327221
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 70