MAUDE Adverse Event Report: LDR MÉDICAL ROI-A MEDIAN IMPLANT HOLDER; ROI-A ALIF CAGE SYSTEM

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This medwatch is submitted to send the initial report of this complaint.Product was not returned yet, no evaluation could be performed.The review of the device history records is ongoing.Investigation still in progress.Not returned to manufacturer yet.
Event or Problem Description
Roi-a: broken instrument.According to the description provided , a cotter pin came apart and fell into the wound.It was retrieved and taken out of patient.The threaded rod striped out of the implant so it could not be controlled.The shaft of the inserter broke off the wing guide so everytime the surgeon hit it with a mallet, it bent over the guide making it impossible to deploy the blade, after many attempts, the doctor decided it was best to remove the blade and cage together.They burred portions of the anterior face of the implant per the surgical technique and removed the blades, then they used a kocher to remove the cage.The threaded rod was not coming out of the implant holder so the tech assembled the radd delivery system to implant the new cage.Following the surgical technique the new cage/blades were implanted.All together the case was delayed around 40-45 mins.No patient complication was notified.Additional information and product return were requested.Investigation still in progress.
Additional Manufacturer Narrative
Correction to: a1, a2 (age), b1, b5, b6, b7, d1, d2 (common device name), d4 (udi number), e1, e2, e3, g3.Additional information: d2 (device product code), d10, e4, g5 (pma/510k), h3, h6 (method, results and conclusions codes) the returned implant holder was evaluated.Visual inspection confirmed that the guide portion of the device had fractured off of the shaft.It is possible that repeated use and sterilization cycles over the lifetime of the device caused the material to gradually weaken over time such that an unexpected off-axis force during use would result in the device fracturing; however, this cannot be conclusively determined based on the information provided.A review of the dhr did not find any issues which would have contributed to this event.
Event or Problem Description
It was reported that during surgery, the inserter shaft broke making the surgeon unable to insert the blade.There was a surgical delay greater than 30 minutes to replace the instrument and complete the procedure.No patient harm was reported.

• Brand Name: ROI-A MEDIAN IMPLANT HOLDER
• Common Device Name: ROI-A ALIF CAGE SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8801579
• Report Number: 3004788213-2019-00236
• Device Sequence Number: 3158298
• Product Code: MAX
• UDI-Device Identifier: 03662663041768
• UDI-Public: 03662663041768
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K153495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: IR9280R
• Device Lot Number: 110136701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 03/31/2020
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 04/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 82 YR