MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG MED H10MM 27X30MM 6; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number N/A

Device Problem Malposition of Device (2616)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2017

Event Type  Injury  

Manufacturer Narrative

Implant discarded.

Event Description

Roi-a : implant position incorrect.Cage was implanted in l5-s1 disc space.Surgeon attempted to implant the first anchor but could not due to the position of the cage.The patient had a high sacral slope and the plate that he was deploying though the cage into s1 was on a trajectory that would have penetrated the outer cortex of the anterior portion of the sacrum.The surgeon wanted to reposition the cage at this point.Implants were removed and new ones were inserted.There was no injury to the patient.Broken implant were discarded 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.From description received, surgeon should have placed the cage forward from the beginning.Additional information were requested to have a better understanding of this case.

Manufacturer Narrative

Additional information received on 30 oct 2017 : it was a two level surgery(reported issue only on one level).For the level where issue occured, plates were removed and implanted again with a new cage.No images will be provided, reporter don't have information about the indication for the initial surgery.No relevant additional information was provided.From description initially received, surgeon should have placed the cage forward from the beginning.

Event Description

Roi-a : implant position incorrect.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.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 review of the case and the recurrence of this type of event for this implant, the likely cause for the event is an operational context.As the patient had a high sacral slope, the cage can be on a trajectory that would have penetrated the outer cortex.Investigation found no evidence on a device issue.

Event Description

Roi-a : implant position incorrect.

• Brand Name: ROI-A CAG MED H10MM 27X30MM 6
• 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
• MDR Report Key: 6950710
• MDR Text Key: 89364053
• Report Number: 3004788213-2017-00144
• 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,Followup
• Report Date: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2022
• Device Model Number: N/A
• Device Catalogue Number: IR2522P
• Device Lot Number: M42593
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 60 YR