MAUDE Adverse Event Report: LDR MÉDICAL AVENUE L CAGE H10MM 17X45MM 6; SEE H10

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Device Handling Problem (3265); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This medwatch is submitted to send the initial report of this complaint.The review of the device history records and traceability did not reveal any non-conformance's to specifications or deviations in procedures that might have contributed to the reported event.Product was received in a condition which made analysis impossible.No evaluation could be performed.Additional information was requested.Investigation ongoing.
Event or Problem Description
Avenue l: anchoring plate stuck in cage and inserter.On (b)(6) 2019, in the process of using avenue_l product, anchoring plate was stuck between the implant holder and the cage.According to the reporter it was due to the bending angle of the anchoring plate, which resulted in the cage and anchoring plate damage.No impact for patient and no delay were reported.Surgical technique was followed.Additional information was received on (b)(6) 2019: the patient is in good health and has been discharged from hospital.X-rays will be provided.The doctor used products of different specifications during the operation.The problem occurred during the first anchor implantation.The patient¿s bones are in good condition without hardening.Additional information was requested.Investigation still in progress.
Event or Problem Description
It was reported that during the procedure the avenue-l anchoring plate was stuck between the implant holder and the cage.The plate bent and damaged the cage.Alternate implants were used to complete the case.There were no reported patient impacts.This is report two of three for this event.
Additional 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.Address: establishment name: (b)(6).The product was not returned and no photos of the product in the jammed state were provided, so an evaluation is unable to be performed.As such, no evaluation results are available and no conclusions regarding the cause can be drawn.A review of the dhr did not find any issues which would have contributed to this event.The part was likely conforming when it left zimmer biomet's control.

• Brand Name: AVENUE L CAGE H10MM 17X45MM 6
• Common Device Name: SEE H10
• Manufacturer (Section D): LDR MÉDICAL; quartier europe de l¿ouest; 5, rue de berlin; sainte-savine 10300 ; FR 10300
• MDR Report Key: 8694634
• Report Number: 3004788213-2019-00167
• Device Sequence Number: 2600729
• Product Code: MAX
• UDI-Device Identifier: 03662663008723
• UDI-Public: 03662663008723
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2020

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 Expiration Date: 04/01/2023
• Device Model Number: N/A
• Device Catalogue Number: IR6330P
• Device Lot Number: 65564
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 06/13/2019
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Age: 57 YR