MAUDE Adverse Event Report: LDR MÉDICAL ROI-A CAG IST H14MM 30X39MM 14; INTERVERTEBRAL FUSION DEVICE WITH INTEGRATED FIXATION, LUMBAR

Model Number N/A

Device Problems Crack (1135); Improper or Incorrect Procedure or Method (2017)

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

Event Date 10/24/2017

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.Additional information have been requested.

Event Description

Roi-a : broken cage.Patient had sclerotic bones.Reporter advised the surgeon to use starter awl but surgeon stated that he didn't need it.He implanted the cage and proceeded to anchor impaction.When he retrieved the implant holder, cage cracked.Cage and plates were removed and replaced by new ones.No impact on patient.Patient had sclerotic bones and surgeon should have used starter awl.Additional information have been requested.

Manufacturer Narrative

Updated for that medwatch report product not returned to the manufacturer then no visual examination could be performed.The surgeon inserted the cage and proceeded to anchor impaction.He noticed that the hole of the threaded rod was cracked when he retrieved the implant holder.The plates and cage were took off and replaced by a similar implant.No impact on the patient.From information initially received, the surgeon decided to not use the starter awl (instrument used to create path and ease insertion of anchoring plate).As described in the surgical technique of roi-a device family, in order to prepare the anchoring plate trajectory, the starter awl is recommended for each roi-a surgery.Then starter awls should have been used by surgeon to create a completed path and avoid the breakage of the cage due to patient hard bone ( case of patient with sclerotic bones.) root cause is related to a user error, investigation found no evidence to indicate a device issue.Not returned to manufacturer.

Event Description

Roi-a : broken cage.

• Brand Name: ROI-A CAG IST H14MM 30X39MM 14
• Type of Device: INTERVERTEBRAL 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: 7048690
• MDR Text Key: 92630822
• Report Number: 3004788213-2017-00204
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Model Number: N/A
• Device Catalogue Number: IR5384P
• Device Lot Number: 16-145684
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Age: 39 YR