MAUDE Adverse Event Report: LDR MEDICAL AVENUE - L CAGE HOLDER; SEE H10

Catalog Number IR90019R

Device Problems Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problem No Code Available (3191)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

Type of the device: 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.

Event Description

It was reported that the avenue l implant threaded rod was bent and became stuck during impaction.This prevented the rod from disengaging from the cage.After an hour of trying to find a solution, the surgeon closed the patient without the procedure being completed.The patient was subjected to a second surgery two days later to perform the initially intended procedure.There were no additional patient impacts reported.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.The complaint is confirmed for one of the returned avenue l cage holder for the failure of being bent.Visual inspection of the returned item reveals a slight bend on the knob.Functional examination using inner thread and implant showed that the device was able to fully engage with the implant according to surgical procedure.Medical records were not provided for review.Potential cause: the cause of the damage cannot be determined at this time since there is no information available regarding how the instrument was being used or handled at the time of the damage.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.Device use: this device is used for treatment.

Event Description

It was reported that the avenue l implant threaded rod was bent and became stuck during impaction.This prevented the rod from disengaging from the cage.After an hour of trying to find a solution, the surgeon closed the patient without the procedure being completed.The patient was subjected to a second surgery two days later to perform the initially intended procedure.There were no additional patient impacts reported.

• Brand Name: AVENUE - L CAGE HOLDER
• Type of Device: SEE H10
• Manufacturer (Section D): LDR MEDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine, n/a 10300 ; FR 10300
• MDR Report Key: 10538506
• MDR Text Key: 207112890
• Report Number: 3004788213-2020-00134
• Device Sequence Number: 1
• Product Code: MAX
• Combination Product (y/n): N
• PMA/PMN Number: K153495
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IR90019R
• Device Lot Number: 410249901/18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention