MAUDE Adverse Event Report: AESCULAP AG ACTIV L SUP.PLATE SIZE S 11/SPIKES; PROSTHESIS, INTERVERTEBRAL DISC

Model Number	SW972K
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If additional information / 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 the activ l implant.The activl implant migrated 4 months after surgery.Original surgery was on (b)(6) 2020; the procedure was a total disc replacement (tdr).Sometime later, the patient was on vacation and did "something in ocean".A revision surgery was necessary.Implant was removed and treatment was fusion on (b)(6) 2020 additional information was not provided.The operative report was not available.The adverse event / malfunction is filed under xc reference (b)(4).Associated medwatch-reports: 2916714-2021-00002, 2916714-2021-00003.
Event or Problem Description
Associated medwatch-reports: 9610612-2020-00956 (b)(4), 9610612-2020-00957 (b)(4), 9610612-2020-00962 (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 the available lot number; 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.

• Brand Name: ACTIV L SUP.PLATE SIZE S 11/SPIKES
• Common Device Name: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11131105
• Report Number: 2916714-2021-00001
• Device Sequence Number: 632087
• Product Code: MJO
• UDI-Device Identifier: 04038653425761
• UDI-Public: 4038653425761
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• 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): 03/12/2021
• Report Date (Section F): 01/07/2021

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: 03/02/2025
• Device Model Number: SW972K
• Device Catalogue Number: SW972K
• Device Lot Number: 52596232
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/15/2020
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/07/2021
• Supplement Report FDA Received Date: 03/12/2021
• 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 Age: 39 YR
• Date Report Sent to FDA: 01/07/2021