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

Model Number N/A

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.The cage was returned to ldr medical: visual and functional evaluation can be performed.The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.There is a crack that spreads through the threaded hole.It's possible that this crack was due to an excessive tightening and/or an concentrated excessive effort on this area like an unwanted angle (between the cage and the inserter) or an excessive effort during the impaction of the first anchoring plate.Regarding the slots, it's possible that the anchoring plate was not follow the correct impaction trajectory: there is friction marks related to a possible angle between the cage and the inserter.Additional information from reporter received on october, 30th 2018: cage was not inserted with an angle.Anchoring plate was not inserted with strength.From information provided by the reporter, based on the product history records, the review of the case and the recurrence of this type of event for these products, the likely cause for the event is a user error (information from the reporter are not coherent with the examination performed by ldr) : an excessive tightening of the cage and/or an concentrated excessive effort like an unwanted angle (between the cage and the inserter) or an excessive effort during the impaction of the first anchoring plate.So no possibility to determine the origin of the user error.The investigation found no evidence to indicate device issue.The root cause is a user error.

Event Description

Roi-a : broken cage during impaction.The reporter assisted a roi-a surgery by dr.(b)(6), a neurosurgeon at (b)(6).After using trial 33x36 h12 in 10 °, the surgeon implanted the corresponding cage.The instrumentalist assembled the cage correctly on the inserter, but when impacting the first half anchoring plate, the cage broke.The surgeon had to remove the anchoring plate and the cage, and implant another cage with another anchoring plates.There was not the same size of cage available, so he finally put a cage 30x33 h12 in 10 °.The end of the implantation went well and the surgeon did not encounter other problem with the second cage.No delay of more than 30 min in surgery.Additional information on october, 02nd, 2018: the patient was in good health after the surgery.There are no xrays.The surgery was completed with a cage with another size because there wasn't in stock the same size.Patient's bones were a little hard but not sclerotic.The surgeon did not used the starter awl.The first anchoring plate was impacted without difficulties.The cage broke during the impaction of the first anchoring plate.It was the inferior plate.The surgeon used the depth stop on the inserter.

Manufacturer Narrative

Corrections to all fields.This mdr report was submitted in error.There is no information available that suggests that there was a malfunction of the device.Additionally, the device did not contribute to a death or serious injury.

Event Description

This mdr report was submitted in error.There is no information available that suggests that there was a malfunction of the device.Additionally, the device did not contribute to a death or serious injury.

• Brand Name: ROI-A ANCHORING PLATE S
• 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
• MDR Report Key: 8019351
• MDR Text Key: 125499016
• Report Number: 3004788213-2018-00358
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• 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: IR2009T
• Device Lot Number: 744199
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1