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

Model Number N/A

Device Problems Difficult to Insert (1316); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initial report of this complaint.Udi of device: (b)(4).The review of the device history records is ongoing.Investigation still in progress.Device evaluated by mfr: remains implanted.

Event Description

Roi-a: anchoring plate didn't deploy.Impossible to deploy anchoring plate in the roi-a cage.Surgeon has used another anchoring plate size m but same issue.He used size s with difficulties, need to use graft compactor to deploy this anchoring plate.Starter awl were used before anchoring plate insertion.The patient had hard bones.The two anchoring plates m initially used were scrapped.It was a delay of 35 minutes due to the extra actions that were needed: take x-rays again, opening material, extracting anchoring plate m, put another anchoring plate m, extract again, and finally put the anchoring plates.X-ray were provided.Not impact for patient.Surgical techniques was followed according to reporter.

Manufacturer Narrative

This medwatch is submitted to send additional information received and the result of the investigation of this complaint : products are not available for evaluation.Anchoring plates m were discarded and anchoring plates s and cages are 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 information provided, based on the product history records, the recurrence of this type of event for this implant and on the fact that the products are not available for evaluation, it is assessed that the event could probably due to patient condition.As reported, the patient had very hard bones, which can hinder the trajectory of the anchors.However , based on the available informations , this conclusion cannot be validated.The investigation found no evidence to indicate device issue.Based on the available informations , the exact root cause remain undetermined with hypothesis of patient condition caused difficulty to deploy the anchoring plates.

Event Description

Roi-a : anchoring plate didn't deploy.During the surgery it was impossible to deploy anchoring plate in the roi-a cage.The slot of the cage seemed smaller.Surgeon has used another anchoring plate size m but same issue occured.He used size s with difficulties, need to use graft compactor to deploy this anchoring plate.It was a delay of 35 minutes due to the extra actions that were needed: take x-rays again, opening material, extracting anchoring plate m, put another anchoring plate m, extract again, and finally put the anchoring plate s.X-ray was provided.The two anchoring plates m initially used were scrapped.The anchoring plate s and the cage remain implanted.Additional information was received on april 18th: patient is doing well.Another image was taken in day 4 post-op without issue identified.Patient had hard bones.Starter awl were used before anchoring plate insertion.The picture sent was taken after the anchoring plate s was implanted and fixed with the help of the graft compactor.Additional information was received on may 2nd: there was no conflict with the pins.The two anchoring plates finally used were implanted and fixed with the help of the graft compactor.They were folded on the top because it was difficult to completely introduce them.Reporter confirmed that there is no more information available for this case.

• 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: 8531353
• MDR Text Key: 142483701
• Report Number: 3004788213-2019-00124
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Model Number: N/A
• Device Catalogue Number: IR2009T
• Device Lot Number: 674643
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other