MAUDE Adverse Event Report: AESCULAP AG ACTIV L INF.PLATE S1 SIZE M 5°/SPIKES; SPINE SURGERY

Model Number	SW986K
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information or investigation results become available, it will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with an activ l inferior plate.According to the complaint description,a postoperative revision occurred due to subsidence.The original implantation was on (b)(6) 2020.Additional information has been requested.The adverse event / malfunction is filed under xc reference (b)(4).Associated components: unknown.
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
No changes required.

• Brand Name: ACTIV L INF.PLATE S1 SIZE M 5°/SPIKES
• Common Device Name: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11693772
• Report Number: 2916714-2021-00060
• Device Sequence Number: 19604139
• Product Code: MJO
• UDI-Device Identifier: 04046963143848
• UDI-Public: 4046963143848
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/06/2022
• Report Date (Section F): 04/20/2021

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: 12/18/2024
• Device Model Number: SW986K
• Device Catalogue Number: SW986K
• Device Lot Number: 52581251
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2021
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 04/06/2022
• 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: 04/20/2021