MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG MED H18MM 30X39MM 14; INTERVERTEBRAL BODY FUSION SYSTEM

Model Number N/A

Device Problems Break (1069); Detachment of Device or Device Component (2907); Device Handling Problem (3265)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

This initial medwatch is submitted to send the result of the investigation of this complaint.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.According to the information provided it is clear that the root cause of the incident (broken cage and anchoring plates) is a user error where the surgeon did not prepare well the implantation of the anchoring plate.The starter awl was not used for the first implantation but it should be used before impacting the anchoring plates seeing that the patient had hard bones.So the surgeon did not follow the surgical technique guide.Surgeon followed the surgical technique for the second implantation (use of starter awl) and there was not issue.The investigation found no evidence to indicate device issue.Root cause : user error (instruction was not followed).Not returned.

Event Description

Roi-a : the inserter became detached from the cage during impaction of anchoring plate.During surgery, while surgeon impacting the first anchoring plate in the cage, the cage and the implant holder detached from each other.The reporter do not know if this was due to the force used for the impaction of the anchoring plate.Patient has hard bones.Cage and anchoring plates were removed.The surgery was completed with new cage and new anchoring plate.During this second implantation, the starter awl was used before insertion of the anchoring plate.Additional information received on oct.12th 2018 by email : the patient is fine.The cage was loaded properly.The tightening was done by hand.The axis and angulations were correct during insertion.Proper steps followed for the impactors.The first anchoring plate never was fully seated as it broke along with the cage.

Event Description

Roi-a : the inserter became detached from the cage during impaction the cage and associated anchoring plates were returned to manufacurer , and examination of actual devices confirmed the event.

Manufacturer Narrative

This medwatch is intended to provide additional information received upon the device examination and to correct the conclusion sent in the previous report the products were received on (b)(6) 2019 , therfore examintaion was performed on the returned product.The reported event is confirmed: the roi-a cage reference ir5345p and lot 910117000r10 is damaged.Considering the fissures starting point, excessive stresses were applied on the roi-a cage thread during the locking of the implant on the implant holder, causing its fracture during the setting-up.From the information provided based on the complaint report description , the product history records, the review of the case with the project manager, the recurrence of this type of event for this product and after having performed the product evaluation, the investigation found no evidence to indicate a device related issue.Indeed, excessive stresses were applied on the cage roi-a thread during the locking of the implant on the implant holder, causing the implant fracture during the setting-up.It is clearly stated in the surgical technique to make sure the cage is perfectly stable and properly fixed on the cage holder (step 6: cage preparation).Root cause : mishandling during cage -inserter assembly.

• Brand Name: ROI-A CAG MED H18MM 30X39MM 14
• 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: 8046418
• MDR Text Key: 126419179
• Report Number: 3004788213-2018-00361
• 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: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: N/A
• Device Catalogue Number: IR5345P
• Device Lot Number: 910117000R10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 41 YR