MAUDE Adverse Event Report: LDR MÉDICAL ROI-A ANCHORING PLATE S; ROI-A ALIF CAGE SYSTEM

Model Number N/A

Device Problems Installation-Related Problem (2965); Appropriate Term/Code Not Available (3191)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 04/30/2018

Event Type  Injury  

Manufacturer Narrative

Without a product return, no product evaluation is able to be conducted.Information received shows :issue occured on first anchoring plate, adjustable stop was used and there was no conflict with adjacent hardware, implant holder was in the good axis and was used to complete the procedure.Starter awl was used to complete the surgery.Surgeon reported patient was fine and the same instrumentation set was used for further surgery without any other issue reported.No x-rays are available, short and final anchoring plate impactor did not reached mechanical stop.Review of traceability and review of the device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Regarding information provided, root cause of the issue cannot be determined.The investigation found no evidence to indicate a device issue.

Event Description

As reported during a roi-a surgery : during the passage of the superior anchoring plate, it was not finalized.We removed the implant holder and found that the anchoring plate was not engaged properly.The patient did not have dense bone so we did not use the scissors.So we did a revision because we could not lock the other anchoring plate.During this revision the cage broke and we therefore set up another implant no harm to the patient.A delay of surgery more then 30 min was reported.

Event Description

It was reported that during an roi-a procedure, a anchoring plate could not be locked in place.It was removed and replaced with an alternative plate.There was a delay longer than 30 minutes, but there were no reported patient impacts associated with the delay.

Manufacturer Narrative

Correction to: a1, a2 (age), b1, b5, b6, b7, d1, d2, d4 (udi number), e1, e2, e3, e4, g3, g5 (pma/510k), h3.Additional information: a5, h6.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.

• Brand Name: ROI-A ANCHORING PLATE S
• Type of Device: ROI-A ALIF CAGE SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7548662
• MDR Text Key: 109398748
• Report Number: 3004788213-2018-00173
• 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: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: N/A
• Device Catalogue Number: IR2009T
• Device Lot Number: 284687/4
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 44 YR