MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORD CAGE H06 14X15.5MM; INTERVERTEBRAL BODY FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/22/2017

Event Type  Injury  

Manufacturer Narrative

Traceability reviewed and inspection record does not reveal any non compliance on this lot.Device not yet received by manufacturer.

Event Description

Roi-c : awl stuck in cage.Starter awl was used because of patient hard bone.First anchoring plate was implanted successfully.While awling for the second anchor, the starter awl was found not to be in the right position and was somehow being blocked.Devices were removed and new ones were implanted successfully.No intraoperative films are available.Device were returned to manufacturer but not yet received.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.From information provided, based on the product history records and after having performed an evaluation on the returned cage , it can be concluded that the cause of the event is a mishandling when impacting the anchoring plate.Indeed, the surgical technique has not been respected.The surgeon has neither inserted the inferior anchoring plate first, nor used fluoroscopy to check correct positioning of the half anchoring plate.Therefore, the first anchoring plate was not correctly inserted and a conflict occurred during the insertion of the awl for the second plate.The review of the device history records and the traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.The investigation found no evidence to indicate a device issue.The root cause : mishandling during anchoring plate insertion , which caused conflict with awl and caused it jammed.

Event Description

Roi-c : awl stuck in cage.Cage returned and was exanimated by manufacturer.

• Brand Name: ROI-C LORD CAGE H06 14X15.5MM
• Type of Device: INTERVERTEBRAL BODY 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
• MDR Report Key: 6882501
• MDR Text Key: 87878012
• Report Number: 3004788213-2017-00097
• Device Sequence Number: 1
• Product Code: OVE
• 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
• Report Date: 12/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2017
• 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: MC1422P
• Device Lot Number: 50882
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 63 YR