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

Model Number N/A

Device Problems Use of Device Problem (1670); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

This medwatch is submitted to send the initial report.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.Investigation on going.Conclusion not yet available.Device not returned to the manufacturer.

Event Description

Roi-c : conflict anchoring plate with caspar pins.From information provided, during a roi-c surgery, the anchoring plate and the cage must have been removed because there was a conflict between caspar pin and anchoring plate.It is due to surgeon has not removed caspar pins during implantation of anchoring plate.No harm on patient.No delay more than 30 minutes on surgery.

Manufacturer Narrative

Correction: a1, b5, d1, d2 (common device name), e1, e2, e3, g3, h1, and h6 (method and results).Additional information: d4 (udi number), g5 (pma/510(k) number), h6 (device and conclusions).D10 - the product was returned to the manufacturer for evaluation; however, the exact date of return is unknown.The returned plate was evaluated.Visual inspection found that the tip of the device is bent.A review of the manufacturing records found no nonconformances or temporary deviations that would have contributed to this failure and the device was likely conforming when it left zimmer biomet's control.The labeling was reviewed and found to contain instructions regarding proper device usage.In the reported incident, the surgeon did not remove the caspar pin prior to installing the anchoring plate.Per the surgical technique guide, it is advised to remove the pins if they have not been placed properly as they can impede anchoring plate preparation and insertion.In this event, the bent anchoring plate was likely caused by the caspar pin being in the trajectory of the anchoring plate.This metal-on-metal contact caused the plate to bend.

Event Description

It was reported that the surgeon did not remove the caspar pin prior to inserting the anchoring plate.As such, the anchoring plate could not be fully installed into the bone.The surgeon removed and replaced the plate after the caspar was removed.There were no reports of patient impacts.

• 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: 8456378
• MDR Text Key: 140119635
• Report Number: 3004788213-2019-00101
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MC1005T
• Device Lot Number: 285793/11
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1