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

Catalog Number IR6001T

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2021

Event Type  malfunction  

Event 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 one of three for this event.

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.

Manufacturer Narrative

Corrections in h3.Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation visual inspection found the part was 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 the dhr was unable to be reviewed since the lot number cannot be determined.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.

Event 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 one of three for this event.

• Brand Name: ANCHORING PLATE S
• Type of Device: 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: 12817157
• MDR Text Key: 281611596
• Report Number: 3004788213-2021-00150
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IR6001T
• 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
• Date Manufacturer Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1