MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG MED H14MM 33X36MM 14; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number N/A

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/04/2017

Event Type  Injury  

Manufacturer Narrative

The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Regarding description provided, surgeon failed to follow surgical technique to choose implant size and to perform x-rays controls.Root cause of the event is related to user error.Implant discarded at hospital.

Event Description

Roi-a : cage too deep.When trialing to decide which size of cage to implant, surgeon refused to make xray control to check if trial was good.After implanting the cage, surgeon refused to make xray control to check if position of the cage was good before anchoring plate impaction.When final xray control was done, after impaction of the anchoring plate, it appeared that cage was too deep.Cage and anchoring plate were removed without difficulty.Products scrapped by hospital new cage and anchoring plate implanted successfully.Surgery was delayed of 30 min.Additional information requested to have details on patient condition.

Manufacturer Narrative

From surgery description it was a roi-a cage too deep.New cage and anchoring plate implanted successfully.Surgery was delayed of 30 min.No information on the state of health of the patient was received despite there being several request for additional information.The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Regarding description provided, surgeon refused to follow surgical technique to choose implant size and to perform x-rays controls after anchoring plates impaction.Root cause of the event is related to user error not to follow surgical technique.

• Brand Name: ROI-A CAG MED H14MM 33X36MM 14
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; 5, rue de berlin; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 7157020
• MDR Text Key: 96147365
• Report Number: 3004788213-2018-00001
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• 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: IR2741P
• Device Lot Number: 16-112101
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention