MAUDE Adverse Event Report: LDR MÉDICAL ROI-A STERILE STR AWL FOR AP; INTERVERTEBRAL BODY FUSION SYSTEM IMPLANT

Model Number N/A

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

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 procédures 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 buttom 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 deciced 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.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation.Additional information was received on june, 1st 2018 : patient condition is good.The review of the device history records of the devices mentioned above did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.It is determined that probable root cause is related to both patient condition and user error.Regarding description provided, the event is probably caused by a sclerotic bone condition of the patient.In addition as reported , the marks on the anchor tip may suggest that the implant holder was not perfectly in the axis of the cage during the anchor impaction.As mentioned in the surgical technique " make sure the impactions are perfectly done in the axis of the intervertebral space.Surgeon considered that cage was stable without fixation and that he will monitor the patient.However , as mentioned in the ifu it's not recommended to keep the implant without anchoring plate as mentioned in the contraindications.Investigation found no evidence on product issue root cause of the event : patient condition combined with user error.Actual situation : off label - surgeon kept the infixed implant in the patient (under monitoring- last information received patient condition is good ).

• Brand Name: ROI-A STERILE STR AWL FOR AP
• 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
• MDR Report Key: 7398681
• MDR Text Key: 104412612
• Report Number: 3004788213-2018-00095
• 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
• Type of Report: Initial,Followup
• Report Date: 06/07/2018

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 Expiration Date: 07/01/2021
• Device Model Number: N/A
• Device Catalogue Number: IR92000R-S
• Device Lot Number: 281182/20
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 68 YR