MAUDE Adverse Event Report: LDR MÉDICAL ANCHORING PLATE M; AVENUE L LATERAL LUMBAR CAGE

Model Number	N/A
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Without a product return, no product evaluation is able to be conducted.The lot number is unknown; therefore the device history records are unable to be reviewed.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 or Problem Description
It was reported that while the surgeon was impacting the second plate, it did not go into the correct slot in the cage holder; it started to go into the first plate's slot and became jammed.The plate could not be removed while the holder was attached to the cage, so the cage and first plate were removed with the holder.The plate was then removed from the cage holder and a new cage and plates were installed to complete the procedure.There was no patient impact or surgical delay.
Additional Manufacturer Narrative
Additional information in h6: component, investigation type, findings, and conclusions.Device evaluation: product was not returned, however photos were provided.It is seen in the photos that the plate is still stuck in the instrumentation post-op.Potential cause root cause was unable to be determined as the product was not returned.This event could possibly be attributed to inserting the plate into the incorrect slot and then applying force prior to attempting to put the plate in the correct slot.It could also be attributed to scratches on the inside of the instrument causing off-path forces guiding the plate into the slot.Dhr review : per dhr review for the plate, the part was likely conforming when it left zimmer biomet control.Device use this device is used for treatment.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 or Problem Description
It was reported that while the surgeon was impacting the second plate, it did not go into the correct slot in the cage holder; it started to go into the first plate's slot and became jammed.The plate could not be removed while the holder was attached to the cage, so the cage and first plate were removed with the holder.The plate was then removed from the cage holder and a new cage and plates were installed to complete the procedure.There was no patient impact or surgical delay.
Additional Manufacturer Narrative
Corrections in d9 and h3.Additional information in h6: investigation type.Device evaluation: visual inspection revealed the returned plate is fractured in three pieces.If additional information is obtained that adds value to the relevant content of this report, a follow-up report will be sent.
Event or Problem Description
It was reported that while the surgeon was impacting the second plate, it did not go into the correct slot in the cage holder; it started to go into the first plate's slot and became jammed.The plate could not be removed while the holder was attached to the cage, so the cage and first plate were removed with the holder.The plate was then removed from the cage holder and a new cage and plates were installed to complete the procedure.There was no patient impact or surgical delay.

• Brand Name: ANCHORING PLATE M
• Common Device Name: AVENUE L LATERAL LUMBAR CAGE
• 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: 11924269
• Report Number: 3004788213-2021-00057
• Device Sequence Number: 3179971
• Product Code: MAX
• UDI-Device Identifier: 03662663008327
• UDI-Public: (01)03662663008327(17)250101(10)786911
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2022

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 Expiration Date: 01/01/2025
• Device Model Number: N/A
• Device Catalogue Number: IR6002T
• Device Lot Number: 786911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/07/2021
• Supplement Date Received by Manufacturer: 09/15/2021; 03/29/2022
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 09/22/2021; 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2020
• 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
• 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 Sex: Female
• Patient Weight: 75 KG