MAUDE Adverse Event Report: LDR MÉDICAL ROI-A ANCHORING PLATE M; INTERVERTEBRAL BODY FUSION SYSTEM

Model Number N/A

Device Problem Positioning Failure (1158)

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

Event Date 12/07/2018

Event Type  Injury  

Manufacturer Narrative

This medwatch is submitted to send the an initial report about a roi-a complaint.The lot# of the anchoring plates still undetermined.The review of the device history records of both lots of anchoring plates is in progress to find if there is any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Information requests are in progress to obtain more information about the incident.Conclusion is not available yet.

Event Description

Roi-a : cage moved back during impaction of anchoring plate two lot number for the same anchoring plate reference were provided in relation with this case.The reporter was not specific about which exact lot number was explanted after first impaction.Additional information are requested, and no answer was received yet.

Manufacturer Narrative

This medwatch is submitted to send the result of the investigation of this complaint.It was reported on january 22nd 2019 that the two anchoring plates references, 285664/5 and 740741, were invoiced the same date december 13th 2018.Therefore, it is unknown which one was used for the surgery.A review of the device history records of each product was done to ensure that there was no non-conformances to specifications or deviations in procedures that might have contributed to the reported event.The review of the device history records and traceablity of both anchoring plate reference did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Several attempts were made to the reporter to collect additional information on this event.Yet, no additional information was received.From the information provided based on the complaint description, the product history records, the review of the case with the product range manager and the recurrence of this type of event for this product, the investigation found no evidence to indicate a device related issue.Indeed, it could be hypothesized that the implant holder was badly manipulated, leading thus to a deterioration of the interface implant / implant holder.Consequently, the cage could have disadapted and moved back, as reported.It is clearly stated in the surgical technique to make sure the cage is perfectly stable and properly fixed on the cage holder (step 6: cage preparation).However, regarding the lack of information provided and without the product return and evaluation, this hypothesis cannot be validated.The root cause of this reported event remains undetermined with the most likely hypothesis of mishandling of cage and inserter assembly.If additional information is received that allows to draw a conclusion, this case will be reopened and the root cause of the complaint will be reevaluated.

Event Description

Roi-a : cage moved back during impaction of anchoring plate according to the reporter , the cage moved during anchoring plate insertion.There was no patient impact , no surgery delay more than 30 min the cage was extracted and replaced with another one of the same reference.Severals attempts were made to collect additional informations about the event.No update received.No clarification , was received from the reporter to identify which anchoring plate lot is related to this event.The cage was discarded by the hospital and not returned to the manufacturer for examination.The anchoring plate related to this event was not returned to manufacaturer.

• Brand Name: ROI-A ANCHORING PLATE M
• 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
• MDR Report Key: 8202191
• MDR Text Key: 131584347
• Report Number: 3004788213-2018-00439
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• 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: IR2008T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1