MAUDE Adverse Event Report: LDR MÉDICAL IMPLANT ROI-C 12X14 H5; LDR SPINE CERVICAL INTERBODY FUSION SYSTEM

Model Number N/A

Device Problems Break (1069); Fracture (1260); Fitting Problem (2183); Material Deformation (2976)

Patient Problems Calcium Deposits/Calcification (1758); No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2018

Event Type  malfunction  

Manufacturer Narrative

Product was not returned yet to manufacturer.The review of the traceability and device history records did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Additional information were requested.Conclusion is not yet available.Investigation still in progress.Device not received yet by manufacturer.

Event Description

Roi-c : cages broke and anchoring plates deformed.It is reported that two cages broke after trying to be implanted with two anchoring plates and the two anchoring plates were deformed.No cages pieces left into the patient and the surgery delayed for 20 min.No impact on patient.One picture suggests one anchoring plate could also be broken.Additional information requested on this point.Update received on may 4th : the problem occured when implanting the first anchoring plate.So the first anchoring plate was not fully seated.The cage was properly assembled on the implant holder.There was no sagittal angulation toward head or foot direction.Surgical technique was respected during impaction.Patient has hard bones, osteophyte and calcification.Investigation still in progress.

Manufacturer Narrative

The returned device was evaluated; however, the decontamination form was not completed correctly.As such, a complete evaluation could not be performed; however, visual inspection of the device confirmed that the cage is broken.A review of the dhr did not find any issues which would have contributed to this event.As a complete evaluation and analysis could not be performed, a cause cannot be determined.

Event Description

It was reported that a cage broke during insertion of the first anchoring plate and the same anchoring plate was bent.A second cage also broke during insertion of the first anchoring plate and the plate was bent.Surgery was completed using a new cage and anchoring plate.There was no patient or surgical impact reported.This is report 1 of 4.

• Brand Name: IMPLANT ROI-C 12X14 H5
• Type of Device: LDR SPINE CERVICAL INTERBODY FUSION SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7513485
• MDR Text Key: 108232274
• Report Number: 3004788213-2018-00151
• Device Sequence Number: 1
• Product Code: ODP
• Combination Product (y/n): N
• PMA/PMN Number: K091088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Model Number: N/A
• Device Catalogue Number: MC1341P
• Device Lot Number: 46938
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1