MAUDE Adverse Event Report: LDR MÉDICAL ROI-A INSET MEDIAN IMPLANT H12MM 30X39MM 10; INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT

Model Number N/A

Device Problems Break (1069); Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/29/2019

Event Type  Injury  

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.Regarding information, root cause of the issue is related to a user error due to repositionning of implant several times which damaged the connection between cage and implant holder.Indeed , as mentioned in the surgical techniques ( step 7a - 7c) it's recommended to make sure that the cage placement is done perfectly in the axis of the intervertebral space.In addition , it's recommended to make a control under fluoroscopy to check the proper positioning of the cage in depth and in rotation.The investigation found no evidence to indicate a device issue.

Event Description

Roi-a : damaged cage during implantation.It was reported that during a roi-a surgery, surgeon repositioned the implant several times, which damaged the connection between cage and implant holder.Cage eventually came off.The implant was changed by an identical one.No surgery delay greater than 10 minutes.No patient impact.According to the reporter , the surgical technique was followed.

• Brand Name: ROI-A INSET MEDIAN IMPLANT H12MM 30X39MM 10
• Type of Device: INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 8543162
• MDR Text Key: 142878862
• Report Number: 3004788213-2019-00129
• Device Sequence Number: 1
• Product Code: OVD
• UDI-Device Identifier: 0366263014342
• UDI-Public: (01)0366263014342(17)220601(10)17-167436
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: N/A
• Device Catalogue Number: IR5372P
• Device Lot Number: 17-167436
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1