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

Catalog Number IR90021R

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 10/28/2021

Event Type  malfunction  

Manufacturer Narrative

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 3004788213-2021-00156.

Event Description

It was reported a cage holder and anchor impactor jammed together intra-operatively.There was a delay of over 30 minutes to detach them, but there were no patient impacts reported.This is report two of two for this event.

Event Description

It was reported a cage holder and anchor impactor jammed together intra-operatively.There was a delay of over 30 minutes to detach them, but there were no patient impacts reported.This is report two of two for this event.

Manufacturer Narrative

Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned and photos were not provided, so a device evaluation could not be completed.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 off-axis forces applied during use.Dhr review the lot numbers were not provided, so the dhrs were unable to be reviewed.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: ANCHORING PLATE IMPACTOR
• 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: 12832516
• MDR Text Key: 281613702
• Report Number: 3004788213-2021-00157
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K153495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IR90021R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Male