MAUDE Adverse Event Report: LDR MÉDICAL ROI-C ANCHORING PLATE; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number N/A

Device Problem Device Slipped (1584)

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

Event Date 10/25/2017

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.Additional information have been requested.Device discarded at hospital.

Event Description

Roi-c : construct becoming loose while impacting anchor the bottom plate was deployed and when surgeon went to deploy the top plate the entire construct became loose.And was removed.Surgery was completed without issue with a higher device.No impact on patient.Additional information have been requested.

Manufacturer Narrative

Additional information was received on 27 nov 2017 : reporter answered to our questions : "the disc space was not distracted, surgeon took the distraction off." "patient bone quality was good." "the adjustable stop was well placed and positioned." received on 14 dec : no images will be provided."anchor was not impacted too hard." "no osteophytes was broken for implantation of the first anchor." "dr.Solomon decided to go up a size as he had to do more bony work after this incident." reporter answered to every questions to try to explain what happened during this surgery.According to all the information reported, data seems not consistent to provide a valid root cause.Moreover, reporter will not be able to get images.From all the descriptions received, root cause is unknown but seems not to be device related.

Event Description

Roi-c : construct becoming loose while impacting anchor.

• Brand Name: ROI-C ANCHORING PLATE
• Type of Device: INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• 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: florence chapaud ; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300 ; 3310648075
• MDR Report Key: 7048038
• MDR Text Key: 92596277
• Report Number: 3004788213-2017-00197
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MC1005T
• Device Lot Number: 281251/20
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2016
• 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 Age: 60 YR