MAUDE Adverse Event Report: LDR MÉDICAL ROI-C SHORT ANCHORING PLATE; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Model Number N/A

Device Problems Break (1069); Difficult to Insert (1316); Malposition of Device (2616)

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

Event Date 02/16/2018

Event Type  malfunction  

Manufacturer Narrative

Product was not returned to the manufacturer.It was discarded by the hospital.No impact on patient was reported.The surgery was delayed less then 30 min.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.According to the descriptions provided of the event as well as the traceability and dhr analysis of the device.The investigation concluded on a root cause related to a hard bone condition of the patient.The investigation found no evidence of a product issue.Device not returned to manufacturer.

Event Description

Roi-c : failure to implant.It was a roi-c surgery.As reported: the c3-c4 level implantation was done without difficulty.On c5-c6, after discectomy, trial was used.Surgeon refused to make x-ray control.(cage was implanted, still without control.First anchor impacted in c6.Surgeon removed the implant holder before reporter would have the time to tell him to impact the second anchor.He feels the cage moved (surgeon uses implant holder without adjustable stop).X ray control was done.Confirmed that position wasn't good.Reporter advised surgeon to remove the cage.Anchor and cage removal was done without difficulty.New cage was implanted (with adjustable stop), but without xray control.(this case is investigated in another report).First anchor was impacted in c6 without difficulty.In c5, difficulty to impact anchor.When removing implant holder, cage was broken.The reporter notified that anchor in c5 is not impacted at all.All the construct was removed.New cage was implanted, with starter awl following the surgical technique.Anchor was impacted without difficulty.

Manufacturer Narrative

D4 (expiration date): sep 1, 2022 or dec 1, 2022.D4 (udi number): (b)(4).The device was not returned for evaluation.However, mri and x-ray images were provided and used for evaluation.Neither image seems to provide evidence of this issue.A review of the dhr did not find any issues which would have contributed to this event.

Event Description

It was reported that during the procedure the roi-c anchoring plate was difficult to insert into c5 vertebrae and was not able to be fully inserted.The surgeon decided to remove the construct and noticed the cage was broken when the implant holder was removed.The cage and anchoring plates were removed and replaced with alternates to complete the case.There were no reported patient impacts.This is report one of two for this event.

• Brand Name: ROI-C SHORT ANCHORING PLATE
• Type of Device: ROI-C TITANIUM-COATED IMPLANT SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7334821
• MDR Text Key: 102250324
• Report Number: 3004788213-2018-00055
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• PMA/PMN Number: K151934
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MC1005T
• Device Lot Number: 283559/6 OR 719750
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 70 YR