MAUDE Adverse Event Report: AESCULAP AG ARCADIUS XP L IMPLANT 4° 25X35X14MM; IMPLANTS INTERBODY FUSION

Model Number	SO814P
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results become available, they will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with an arcadius xp l implant.According to the complaint description, the cage split during impaction in an anterior lumbar interbody fusion (alif) procedure.The inserter was tight to the cage and the cage was being inserted in a superior to downward inferior angle into l5-s1.There was a delay of about 3 minutes required to retrieve the broken piece and open a new cage.The adverse event is filed under xc reference (b)(4).
Additional Manufacturer Narrative
Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.The device history records (dhr) were reviewed for all available lot numbers; the devices were found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
Event or Problem Description
Investigation complete.

• Brand Name: ARCADIUS XP L IMPLANT 4° 25X35X14MM
• Common Device Name: IMPLANTS INTERBODY FUSION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12365644
• Report Number: 2916714-2021-00176
• Device Sequence Number: 6810942
• Product Code: OVD
• UDI-Device Identifier: 04046964043604
• UDI-Public: 4046964043604
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2022
• Report Date (Section F): 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2025
• Device Model Number: SO814P
• Device Catalogue Number: SO814P
• Device Lot Number: 52630676
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/21/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/24/2021