MAUDE Adverse Event Report: LDR MÉDICAL ROI-A IMPLANT HOLDER; INTERVERTEBRAL BODY FUSION SYSTEM

Model Number N/A

Device Problems Break (1069); Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  Injury  

Manufacturer Narrative

The review of the inspection records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.The devices were returned to the manufacturer except for the cage lot #17-167439 (still implanted) the visual examination of the received cage shows cracks near insertion slots.The visual examination of the anchor plate shows marks at the bottom due to ablation and at the top which indicates a resistance during insertion.No visible marks on the starter awl.Inserter used for the surgery was inspected upon reception by the manufacturer and was judged compliant.Investigation still in progress.

Event Description

Roi-a insert : anchors didn't deploy and broken cage.Surgery on (b)(6) 2018, roi-a insert.Level l5-s1 surgeon chooses to implant a cage 30*39 h14 with anchoring plate size m.Cage was in place, surgeon decided to implant first the anchoring plate towards s1.The impaction has been made without effort until the stop.He noticed that the cage has moving forward and the cage was disassembled from implant holder.Anchoring plate was not totally implanted (~60%) surgeon removed cage and anchoring plate with the hook.He saw that the cage was broken anteriorly.He decided to implant another cage, same size.The assembly of implant to implant holder was verified.It was correct.The new cage was in place and he impacted the same anchoring plate towards s1.Same issue happened.He noticed that the segment is distracted.He concluded that there was hard bone at s1.He removed the cage and anchoring plate.Cage was not broken.He used again this cage because he had no more this size of implant in warehouse.The assembly cage-implant holder is not great because threading is damaged.He used awl starter in l5 but at half impaction, the cage moved forward.Surgeon decided to stop and not implanted any anchoring plates.No anterior plate has been implanted because he hadn't any lumbar anterior plate in the healthcare center.Surgeon considered that cage was stable without fixation.Surgeon decided to set up a specific monitoring of the patient (especially concerning potential migration of implant).No harm to the patient.Delay 15 min.

• Brand Name: ROI-A IMPLANT HOLDER
• Type of Device: INTERVERTEBRAL BODY FUSION SYSTEM
• 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: 7398703
• MDR Text Key: 104419720
• Report Number: 3004788213-2018-00097
• Device Sequence Number: 1
• Product Code: OVD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IR9280R
• Device Lot Number: 110097201
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 68 YR