MAUDE Adverse Event Report: LDR MÉDICAL ANCHOR PLATE IMPACTOR; AVENUE L LATERAL LUMBAR CAGE, AVENUE T TLIF CAGE SYSTEM, ROI-A ALIF CAGE SYSTEM,

Catalog Number	IR90021R
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a cage holder, impactor, and plate all became jammed together during surgery and could not be disassembled.There was a delay associated with trying to get the holder and impactor unstuck from the plate, but there were no impacts to the patient.This is report three of three for this event.
Additional Manufacturer Narrative
Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.Reference reports 3004788213-2021-00150 through 3004788213-2021-00152.
Event or Problem Description
It was reported that a cage holder, impactor, and plate all became jammed together during surgery and could not be disassembled.There was a delay associated with trying to get the holder and impactor unstuck from the plate, but there were no impacts to the patient.This is report three of three for this event.
Additional Manufacturer Narrative
Corrections in d4: udi number and h3.Additional information in h4 and h6: component, investigation type, findings, and conclusions.Device evaluation visual inspection did not identify any damage, but the part was found to be stuck with mating components.Potential cause root cause was unable to be determined.This event could possibly be attributed to wear through use over time or multiple sterilization cycles.It could also be attributed to inserting the plate off-axis or not inserting the first plate far enough.Dhr review per dhr review, the parts were likely conforming when they left zimvie control.Device use these devices are used for treatment.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.

• Brand Name: ANCHOR PLATE IMPACTOR
• Common Device Name: AVENUE L LATERAL LUMBAR CAGE, AVENUE T TLIF CAGE SYSTEM, ROI-A ALIF CAGE SYSTEM,
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer (Section G): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, na 10300 ; FR 10300
• Manufacturer Contact: kim martinez ; 10225 westmoor dr.; na; westminster, CO 80021 ; 3035144809
• MDR Report Key: 12817160
• Report Number: 3004788213-2021-00152
• Device Sequence Number: 20072950
• Product Code: MAX
• UDI-Device Identifier: 03662663039642
• UDI-Public: (01)03662663039642(10)10174702/03
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: IR90021R
• Device Lot Number: 10174702/03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2021
• Supplement Date Received by Manufacturer: 04/29/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 05/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/22/2010
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown