MAUDE Adverse Event Report: LDR MÉDICAL ROI-A ANCHORING PLATE M; INTERVERTEBRAL BODY FUSION SYSTEM

Model Number N/A

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2019

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initial report and the result of the investigation.Product was not returned as still implanted.The 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.From the information provided based on the event description, the product history records and the recurrence of this type of event for this product, the investigation found no evidence to indicate a device related issue.Indeed, it is more than likely that the surgeon incorrectly fixed the cage on the cage holder, causing the cage to undergo damage during the setting-up.The surgical technique describes the correct way of using the device without damaging it, underlining the importance to fix well the implant on the implant holder.Indeed, it is clearly stated to make sure the cage is perfectly stable and properly fixed on the cage holder (step 6: cage preparation).However, regarding the lack of information provided and without the product return and evaluation, this hypothesis cannot be validated.The root cause of the reported event remains undetermined with the most likely hypothesis of mishandling during cage insertion on the disc space.If additional information is received that allows to draw a conclusion,another report will be sent.

Event Description

Roi-a: broken implanted device then removed.A zimmer biomet employee reported on (b)(6) 2019 that during roia surgery the implant broke during insertion.No impact on patient or surgery incidence were reported.Additional information received on (b)(6) 2019: the roi-a cage broke during its implantation.The surgeon removed the broken cage and replaced it with another one.The surgery was completed with the same anchoring plate.Additional information received on (b)(6) 2019: the surgeon did not provide much information concerning the reported event.The surgeon reported that the cage broke during it's insertion.The surgeon succeeded in removing the whole cage without retaining any foreign body into the patient's body.The surgery was not delayed.The patient is fine.Additional information received on (b)(6) 2019: the cage was discarded.The anchoring plates were implanted into the patient's body with a new cage.No damages reported on the anchoring plates.

• Brand Name: ROI-A ANCHORING PLATE M
• Type of Device: INTERVERTEBRAL BODY FUSION SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8399939
• MDR Text Key: 138138674
• Report Number: 3004788213-2019-00065
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: N/A
• Device Catalogue Number: IR2008T
• Device Lot Number: 285485/2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1