MAUDE Adverse Event Report: LDR MÉDICAL ROI-A MEDIAN IMPLANT PXL : 23X26 H 12MM 10 DEGREES; ROI-A ALIF CAGE SYSTEM

Catalog Number	IR2433P
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that upon malleting the implant into the patient's lumbar spine at l5-s1, the cage cracked and a piece broke at the point of attachment in the area of the threaded rod; the fractured piece was recovered.The implant and first plate were removed and new ones were placed to complete the procedure without patient impacts.
Additional 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.
Event or Problem Description
It was reported that upon malleting the implant into the patient's lumbar spine at l5-s1, the cage cracked and a piece broke at the point of attachment in the area of the threaded rod; the fractured piece was recovered.The implant and first plate were removed and new ones were placed to complete the procedure without patient impacts.
Additional Manufacturer Narrative
Corrections in d4: udi number.Additional information in d4: expiration date, h4, and h6: component, investigation type, findings, and conclusions.Device evaluation product was not returned and photos were not provided.Device evaluation could not be completed.Potential cause root cause was unable to be determined.This event could possibly be attributed to not using the starter awl or inserting the plates off-axis.Dhr review per dhr review, the part was likely conforming when it left zimvie control.Device use this device is 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: ROI-A MEDIAN IMPLANT PXL : 23X26 H 12MM 10 DEGREES
• Common Device Name: 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: 14337382
• Report Number: 3004788213-2022-00035
• Device Sequence Number: 17708588
• Product Code: MAX
• UDI-Device Identifier: 03662663011136
• UDI-Public: (01)03662663011136(17)240401(10)M55508
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K153495
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

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: 04/01/2024
• Device Catalogue Number: IR2433P
• Device Lot Number: M55508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2022
• Supplement Date Received by Manufacturer: 08/17/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female