MAUDE Adverse Event Report: LDR MÉDICAL ROI-A ANCHORING PLATE M; SEE H10

Model Number	N/A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Common device name: avenue l lateral lumbar cage, avenue t tlif cage system, roi-a alif cage system, roi-t implant system.Without a product return, no product evaluation is able to be conducted.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Reference report 3004788213-2020-00231.
Event or Problem Description
It was reported that a revision surgery was performed to address an roi-c plate that migrated out of its mating cage post-operatively.The superior plate was removed but the cage and inferior plate were not exchanged since they did not migrate.The reporter related the superior plate was difficult to install during the initial procedure; the starter awl was used and the patient had hard bone.This is report one of two for this event.
Additional Manufacturer Narrative
Summary: the complaint is confirmed for one (1) of one (1) returned roi-a anchoring plate (pn ir2008t) for the failure of post-op migration.Medical records were not provided for review.Device evaluation: the plate was returned and visually inspected.The part and lot numbers match the reported information and the plate has damage consistent with postop migration.This complaint is confirmed.Potential cause: root cause was unable to be determined.This event could possibly be attributed to difficulty inserting the plate during initial procedure, as stated in the complaint description.That could possibly be attributed to pre-existing patient conditions, or factors around the surgery and use of instrumentation.Dhr review and related actions per dhr review, the part was likely conforming when it left zimmer biomet control.No actions required.This event is not related to any current actions or recalls or product holds.A follow-up report will be submitted if new information is received that changes the information provided in this report.Reference report 3004788213-2020-00231-1.
Event or Problem Description
It was reported that a revision surgery was performed to address an roi-c plate that migrated out of its mating cage post-operatively.The superior plate was removed but the cage and inferior plate were not exchanged since they did not migrate.The reporter related the superior plate was difficult to install during the initial procedure; the starter awl was used and the patient had hard bone.This is report one of two for this event.

• Brand Name: ROI-A ANCHORING PLATE M
• Common Device Name: SEE H10
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, n/a 10300 ; FR 10300
• MDR Report Key: 11072392
• Report Number: 3004788213-2020-00230
• Device Sequence Number: 19545535
• Product Code: MAX
• UDI-Device Identifier: 03662663010986
• UDI-Public: (01)03662663010986(17)250601(10)288203/3
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K153495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: 06/01/2025
• Device Model Number: N/A
• Device Catalogue Number: IR2008T
• Device Lot Number: 288203/3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 12/24/2020
• Supplement Report FDA Received Date: 02/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention