MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORDOTIC IMPLANT 12X15,5 H8; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Model Number N/A

Device Problems Bent (1059); Crack (1135); Difficult to Advance (2920)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

Without a product return, no product evaluation can be conducted.Review of traceability and 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.One probable root cause of this issue can be related to patient hard bone but regarding information provided, root cause can not be determined.The investigation found no evidence to indicate a device issue.If additional information is obtained that adds value to the relevant content of this report or it conclusion , a follow-up report will be sent.Device not returned as discarded.

Event Description

Roi-c: broken cage and bent anchoring plate.As reported, during a roi-c surgery: " there was 1 cage and 2 sets of anchoring plates wasted.The bent plate was the second anchoring plate from t he first box.When impacted, it would not advance.Reporter asked the surgeon to pull the plate to look and they saw it was bent.Then, they opened a second box to complete the implantation.The anchoring plate went in no problem.They removed the holder to find the peek cracked and missing.Upon removal, the blades were compromised and wasted, along with the 1 cage.The cage was assembled properly, axis was respected and the surgical technique was followed.The issue occurred with the second blade, which was put in the bottom slot going towards the head.There was no starter awl used before or after the incident.The first anchoring plate was fully seated prior to the second plate being inserted.They were not inserted into the same slot and the large u shaped depth stop was used.Patients bone was not very sclerotic either.According the event report: there was no surgery delay more then 30 min.There was no impact on patient or product pieces left into the patient.

Event Description

It was reported that a roi-c cage was found cracked after impacting the associated anchoring plate.The cage and anchoring plate were removed and discarded.A second cage and second pair of anchoring plates were used to complete the procedure.The patient and surgery were not affected in any other way from this event.

Manufacturer Narrative

The implant was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the dhr did not find any issues which would have contributed to this event.

• Brand Name: ROI-C LORDOTIC IMPLANT 12X15,5 H8
• 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: 7572570
• MDR Text Key: 110176521
• Report Number: 3004788213-2018-00183
• 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: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: N/A
• Device Catalogue Number: MC1454P
• Device Lot Number: 52817
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 75 YR