MAUDE Adverse Event Report: LDR MÉDICAL ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM; INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT

Model Number N/A

Device Problem Break (1069)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/04/2019

Event Type  Injury  

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 3 cages and instrument.Instrument broken during insertion of roi-a cage.3 cages have broken.Surgery delayed 2 hours.No informations received on patient impact.Additional information was requested.Investigation ongoing.

Manufacturer Narrative

H3 "no information" entered in error.Correction to: a1, b1, b2, b5, b6, b7, d1, d2, e1 (title), e3, g3, h3, h6 (patient, results and method codes).Additional information: d4 (udi number), d10, e1 (middle name, email, address ¿ line 2, zip code, telephone number), g5 (pma/510k), h6 (conclusion codes).The device was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was reported that an implant holder as well as three cages broke during cage installation.There was a surgical delay greater than 30 minutes.No further surgical or patient information was provided.This is report 3 of 3 for this event.

• Brand Name: ROI-A INSET MEDIAN IMPLANT H14MM 30X39MM
• Type of Device: 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: 8825322
• MDR Text Key: 152171888
• Report Number: 3004788213-2019-00250
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2023
• Device Model Number: N/A
• Device Catalogue Number: IR5384P
• Device Lot Number: 18-238680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other