MAUDE Adverse Event Report: LDR MEDICAL ROI-A MEDIAN IMPLANT PL : 3033 H 12 MM 10; ROI-A ALIF CAGE SYSTEM

Catalog Number IR2632P

Device Problem Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/06/2019

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 during the procedure the cage cracked during impaction.They removed the implant and completed the case with an alternate cage.There were no reported patient impacts or surgical delays.

Event Description

It was reported that during the procedure the cage cracked during impaction.They removed the implant and completed the case with an alternate cage.There were no reported patient impacts or surgical delays.

Manufacturer Narrative

Additional information in b4, d10, g4, g7, h2, h3, h6: methods, results, and conclusion codes.The returned cage was evaluated.Visual examination of the device shows that the cage is cracked.The complaint is confirmed.A review of the manufacturing records did not identify any issues which would have contributed with this event.Labeling was verified to contain instructions for proper use.Likely causes of the cracked cage can be attributed to off-axis impaction or off-axis insertion of the cage.Since the crack was noticed after the attempt to install the plates, it is also possible that the plates were not inserted in the proper orientation.A definitive root cause cannot be determined.

Event Description

It was reported that during the procedure the cage cracked during impaction.They removed the implant and completed the case with an alternate cage.There were no reported patient impacts or surgical delays.

Manufacturer Narrative

The implant was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was reported that during the procedure the cage cracked during impaction.They removed the implant and completed the case with an alternate cage.There were no reported patient impacts or surgical delays.

• Brand Name: ROI-A MEDIAN IMPLANT PL : 3033 H 12 MM 10
• Type of Device: ROI-A ALIF CAGE SYSTEM
• Manufacturer (Section D): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• MDR Report Key: 9173597
• MDR Text Key: 162946461
• Report Number: 3004788213-2019-00303
• 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: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/15/2020

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: Health Professional
• Device Catalogue Number: IR2632P
• Device Lot Number: M42480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/12/2019
• Initial Date FDA Received: 10/09/2019
• Supplement Dates Manufacturer Received: 12/03/2019; 01/29/2020; 05/13/2020
• Supplement Dates FDA Received: 12/04/2019; 02/27/2020; 05/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1