MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG MED H16MM 30X33MM 14; INTERVERTEBRAL BODY FUSION SYSTEM

Model Number N/A

Device Problems Inadequacy of Device Shape and/or Size (1583); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 01/23/2018

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 on patient condition will be provided later by reporter.Investigation is in progress.No information about device return.

Event Description

Roi-a : size issue.Surgeon implanted the cage but it was too lateral.Reporter explained that the cage was too "lateralized", which means not large enough.It was a positioning issue linked to cage size issue.Surgeon changed the cage and implanted a new one (larger).According to reporter, trial were used following the surgical technique, and size chosen when trailing (less deep & large) was supposed to fit too.

Manufacturer Narrative

Product was not returned to ldr medical, no examination can be performed.The review of the device history records and traceability did not reveal any non-conformance to specifications or deviations in procedures that might have contributed to the reported event.Regarding information provided, root cause of this issue is not device related.The event is probably due to an incorrect implant size selection which lead to an incorrect placement.The investigation found no evidence to indicate a device issue.

Event Description

Roi-a : size issue.Cage was too lateralized so not large enough.That is why surgeon changed cage size.Trial were used, but a less deep and large cage was also appropriate.Surgery was delayed (20 to 30 min).No information about patient state of health , no x-rays and no other information were provided after several attempts.

• Brand Name: ROI-A CAG MED H16MM 30X33MM 14
• 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: 7269229
• MDR Text Key: 99986503
• Report Number: 3004788213-2018-00037
• 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: 04/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: N/A
• Device Catalogue Number: IR2643P
• Device Lot Number: M32110C134
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1