MAUDE Adverse Event Report: LDR MÉDICAL AVENUE T ANCHORING PLATE M; INTERVERTEBRAL BODY FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Difficult To Position (1467); Malposition of Device (2616)

Patient Problem Pain (1994)

Event Date 02/22/2018

Event Type  Injury  

Manufacturer Narrative

The review of the device history records and traceability did not reveal any non-conformances to specifications or deviations in procedures that might have contributed to the reported event.Information provided shows that patient condition is good following the revision surgery.Investigation is in progress.Additional information was requested.

Event Description

Avenue-t : revision due to migration patient had an initial surgery in (b)(6) 2018.He was implanted with 2 avenue-t cages but still had pain after surgery.From description received, "surgeon thinks it is due to a cage too posterior.It was hard for him to place this cage during initial surgery due to bleeding (patient had lots of operation)".Surgeon decided to do revision.During surgery, it was noticed on images that one anchor had migrated.It was removed without difficulty and surgeon decided to leave the cage with one anchor.According to surgeon, patient pain was due to anchor migration and not cage positioning because patient pain appeared only few days after surgery.

Manufacturer Narrative

Pictures taken of the product shows marks on anchoring plate tip and near to revision hole product evaluation determined to be compliant.According to the information provided, it is difficult to conclude on the origin of the issue as the images are not clear enough to provide information on the investigation.But the surgeon thinks that may be the bleeding issue is the root cause.The investigation found no evidence to indicate a device issue.Root cause of this event is unknown.If additional information were received that have impact on this investigation another report will be sent.

Event Description

Update received after a meeting of r&d manager and the surgeon on (b)(6) 2018: the different post-op images were reviewed by surgeon with r&d leader, but quality wasn't good enough to determine wether or not the anchoring plate was well in place.No copy of x-rays were provided.They noticed that the first cage was a little bit too centered and the second cage was in contact with the first one.Surgeon confirmed that when he impacted the second cage, he hit the first cage.This could have compromized the association between cage and implant holder.Surgeon also says that at this moment, patient was bleeding a lot, there was a breach in dura mater.It was a high risk patient was aortic implant, and special anesthesic treatment.Surgeon was more concerned about this bleeding than positioning of the cage and anchoring plate impaction.This event may be at the origin of the issue.To sum up, it is difficult to conclude on the origin of the issue as the images are not clear enough to provide information on the investigation.But the surgeon thinks that may be the bleeding issue is the root cause.

• Brand Name: AVENUE T ANCHORING PLATE M
• Type of Device: INTERVERTEBRAL BODY FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 7348224
• MDR Text Key: 102719039
• Report Number: 3004788213-2018-00064
• Device Sequence Number: 1
• Product Code: MAX
• 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: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Model Number: N/A
• Device Catalogue Number: AT0008T
• Device Lot Number: 674560
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1