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

Model Number SW986K

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 03/23/2021

Event Type  Injury  

Manufacturer Narrative

If additional information or investigation results become available, it will be provided in a supplemental report.

Event 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.

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 Description

No changes required.

• Brand Name: ACTIV L INF.PLATE S1 SIZE M 5°/SPIKES
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11693772
• MDR Text Key: 252002065
• Report Number: 2916714-2021-00060
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 04046963143848
• UDI-Public: 4046963143848
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/20/2021,04/06/2022

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
• Device Operator: Health Professional
• 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
• Date Report Sent to FDA: 04/20/2021
• Distributor Facility Aware Date: 03/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention