MAUDE Adverse Event Report: LDR MÉDICAL ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM; SEE H10

Model Number N/A

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

This medwatch is submitted to send the initial report of this complaint.Product was not returned yet, no evaluation could be performed.The review of the device history records is ongoing.Investigation still in progress.Not returned to manufacturer yet.

Event Description

Roi-a: broken cage.Implantation of a roi-a inset cage after metal removal of a synfix cage from depuy spine in l5-s1.When inserting the anchor plates, the roi-a is broken at the attachment interface to the cage holder.Whether the cage is broken when looking up the anchor plates or when inserting.No patient impact or surgery delay reported.Additional information was received on july 5th: according to the reporter , the patient had not hard bones and the starter awl was not used to prepare the anchoring plate insertion.The cage broke after implantation of the second anchor.Also , the cage was properly assembled with the holder.According to visual inspection, it was mounted correctly.It may be possible that the cage has been mounted incorrectly.Since the cage-holder according to x-ray had shifted slightly at the final impact.The axis of the disc space was respected , and the surgical technique was respected for anchoring plate impaction sequence (use of impactor #1 then impactor #2).The first anchoring plate was fully seated.According to the reporter , it's not possible that two anchors were implanted in the same slot.Investigation ongoing.

Manufacturer Narrative

D2: this product has since been withdrawn from the market, however, it is most closely associated with the common device name of "roi-a alif cage system".Correction to: a1, a2 (age), b5, b6, d1, d2 (common device name), d4 (udi number), e1, e2, e3, e4, g3, h1.Additional information: b7, d10 (return date unknown), g5 (pma/510k), h3, h6 (method, results and conclusions codes).The returned device was evaluated; however, the decontamination form was not completed correctly.As such, a complete evaluation could not be performed; however, visual inspection of the device confirmed that the cage was fractured.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was reported that during surgery, a cage broke during insertion of the anchoring plates.There was no reported patient or surgical impact.

• Brand Name: ROI-A INSET MEDIAN IMPLANT H16MM 30X39MM
• Type of Device: SEE H10
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8788291
• MDR Text Key: 150958318
• Report Number: 3004788213-2019-00211
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 03662663014366
• UDI-Public: 3662663014366
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• 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: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: N/A
• Device Catalogue Number: IR5376P
• Device Lot Number: 17-167438
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 89