MAUDE Adverse Event Report: LDR MÉDICAL ROI-C IMPLANT; INTERVERTEBRAL BODY FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the initial report and the result of the investigation of this complaint.Roi-c devices are not returned as they are still implanted.No visual examination could be performed.The reporter has no information about the reference/lot of the cages roi-c concerned.No sales order was provided.Therefore, it was not possible to perform the review of the device history records.From information provided, based on the x-rays analysis and the review of the case, it is assessed that the cause of the prodisc revision is not related to the roi-c devices.Additionally, in this case the patient had implanted two levels for roi-c before revision and three levels after revision.The instruction for use (ifu) mention that: the roi-c implant system & roi-c titanium- coated implant system are indicated for use in skeletally mature patients with degenerative disc disease (ddd) of the cervical spine with accompanying radicular symptoms at one disc level from c2¿t1.As the use of roi-c devices is not allowed for more than one level, the device was used in a off-label manner.The investigation found no evidence to indicate device issue.Root cause: the probable cause of this event is an off-label use of device (instruction was not followed).If any further information is found which would change this evaluation, a follow-up report will be sent.

Event Description

Roi-c: revision of device non-ldr due to possible non fusion of roi-c.It was reported that a revision surgery occured and another manufacturer prothesis was removed.However , according to the description, the event may be related to a ldr product ( roi-c cage).On an unknown date, the patient underwent a removal surgery, the prodisc c was at c3-c4, there were 2 ldr roi-c c4-c6.C5-c6 roi-c did not fuse.The surgeon felt that the non-fusion was the reason that the prodisc c ( another manufacturer's device) was in spondylolisthesis.The device was successfully removed.It was unknown if there was a surgical delay.Procedure outcome and patient status are unknown.It was reported on april 9th 2019 that the initial surgery for the implantation of the prodisc (non ldr medical device) was in (b)(6) 2013.The revision surgery was performed in the (b)(6) medical center.Revising surgeon did not perform original surgery.X-rays before revision were provided.No information about: reference/lot of roi-c devices, sales order for the surgeries and contributing conditions related to the event.It was reported on april 10th 2019 that in revision surgery only prodisc device was removed and it was replaced by another device roi-c.No information of whether the prodisc and roi-c were implanted at the same time.No information of initial diagnosis or if the patient is smoker.Surgeon felt the non fusion of the roi-c was the reason that the prodisc was in spondylisthesis.

• Brand Name: ROI-C IMPLANT
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE WITH INTEGRATED FIXATION, CERVICAL
• 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: 8539149
• MDR Text Key: 142753288
• Report Number: 3004788213-2019-00127
• Device Sequence Number: 1
• Product Code: OVE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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