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

Model Number	N/A
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2019
Type of Reportable Event	Malfunction
Additional 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 is ongoing.Investigation still in progress.Not returned to manufacturer yet.
Event or Problem 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 serious delay was report.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.
Event or Problem 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.
Additional 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.

• Brand Name: ROI-A ANCHORING PLATE L
• Common Device Name: INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8788298
• Report Number: 3004788213-2019-00212
• Device Sequence Number: 16644101
• Product Code: OVD
• UDI-Device Identifier: 03662663010979
• UDI-Public: 03662663010979
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: N/A
• Device Catalogue Number: IR2007T
• Device Lot Number: 671502
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/02/2019
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 03/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 89