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
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported that there was an issue with sw986k-activ l inf.Plate s1 size m 5°/spikes.According to the complaint description,a postoperative revision occurred due to subsidence.The original implantation was on (b)(6) 2020.Additional information was not provided.The adverse event / malfunction is filed under aag reference (b)(4).Associated components: unknown.
Additional Manufacturer Narrative
Investigation results: up to now the products were not provided.Therefore, no investigation was possible.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all leading device(s) lot numbers and the products found to be according to our specification valid at the time of production.There are no similar complaints against the same lot number(s) with this error pattern.Explanation and rationale/conclusion and root cause: because there are no products and only minor information available, a definitive root cause analysis is not possible.Following causes are possible: - wrong system configuaration selected by the user.- wrong implant size chosen by the user.- end plate formed too stron by the user.- design layout unsuitable.- inadequate patient behaviour.Because the device history record is without deviation, a material defect or manufacturing failure can be excluded.No capa 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
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11686365
• Report Number: 9610612-2021-00312
• Device Sequence Number: 3015027
• Product Code: MJO
• UDI-Device Identifier: 04046963143848
• UDI-Public: 4046963143848
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown