MAUDE Adverse Event Report: LDR MÉDICAL ROI-C LORDOTIC IMPLANT 12X14 H6; ROI-C TITANIUM-COATED IMPLANT SYSTEM

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Code Available (3191)
Date of Event	06/18/2019
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.
Event or Problem Description
Roi-c: 3 broken cages and bent awl.According to the available description , the surgeon was impacting anchoring plate with impactor 1 then 2 at c5-6 when peek cage cracked (12x14 h6).He removed the anchoring plates and peek debris.He proceeded to try it again with a new peek cage and plates (12 x14 h6) and again the peek cracked just like before.He removed the anchoring plates and peek debris.The reporter suggested the awl and using a new inserter and he agreed to do both.After using the awl and new inserter he implanted the new peek and plate (12x14 h6) cracked again following impactor 1 & 2.The awl was also bent at the tip after impacting.Surgery delayed 1 hour.No patient impact or serious injury was reported.Additional information was requested.Investigation ongoing.
Event or Problem Description
It was reported that 3 cages broke while impacting the anchoring plate.The surgery was delayed over 30 minutes to remove and replace the devices.This is report 2 of 3.
Additional Manufacturer Narrative
Additional information: b7, g5 (pma/510k), h6 (method, results and conclusions codes) the implant was not returned for evaluation, so no results are available and no conclusions can be drawn.A review of the dhr did not find any issues which would have contributed to this event.

• Brand Name: ROI-C LORDOTIC IMPLANT 12X14 H6
• Common Device Name: ROI-C TITANIUM-COATED IMPLANT SYSTEM
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8788791
• Report Number: 3004788213-2019-00221
• Device Sequence Number: 2102930
• Product Code: OVE
• UDI-Device Identifier: 03662663016537
• UDI-Public: 3662663016537
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K151934
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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 Expiration Date: 03/01/2023
• Device Model Number: N/A
• Device Catalogue Number: MC1442P
• Device Lot Number: 56551
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 03/30/2020
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 04/28/2020
• 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: 63 YR