MAUDE Adverse Event Report: LDR MÉDICAL ROI-A MEDIAN IMPLANT PXL : 27X30 H 12 MM 10 DEG.; ROI-A ALIF CAGE SYSTEM

Catalog Number IR2532P

Device Problem Crack (1135)

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

Event Date 04/20/2023

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 an roi-a cage broke, allowing it to detach from implant holder while the first plate was being installed intraoperatively.The cage and plate were removed and replaced with another cage and both plates were successfully installed to complete the procedure.There was a delay of 20 minutes without patient impacts.

Manufacturer Narrative

Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation: the returned device matches the information in the complaint file and was examined.Visual inspection revealed that the cage was fractured.Root cause: a definitive root cause cannot be determined with the information provided.This event could possibly be attributed to off-axis forces applied on the cage during anchoring plate insertion.Dhr review: per dhr review, the part was likely conforming when it left zimvie control.Device usage: this device is used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

Event Description

It was reported that an roi-a cage broke, allowing it to detach from implant holder while the first plate was being installed intraoperatively.The cage and plate were removed and replaced with another cage and both plates were successfully installed to complete the procedure.There was a delay of 20 minutes without patient impacts.

• Brand Name: ROI-A MEDIAN IMPLANT PXL : 27X30 H 12 MM 10 DEG.
• Type of Device: 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
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: sabrina abla ; 10225 westmoor dr.; na; westminster, CO 80021 ; 7206965158
• MDR Report Key: 16973320
• MDR Text Key: 315658803
• Report Number: 3004788213-2023-00045
• Device Sequence Number: 1
• Product Code: MAX
• UDI-Device Identifier: 03662663011358
• UDI-Public: (01)03662663011358(17)270501(10)M72880
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153495
• Exemption Number: 5645646
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

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
• Device Operator: Other
• Device Catalogue Number: IR2532P
• Device Lot Number: M72880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/24/2023
• Initial Date FDA Received: 05/22/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: PLATE, IR2008T LOT 289685/1
• Patient Sex: Prefer Not To Disclose
• Patient Ethnicity: Non Hispanic