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

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 246078270
• Report Number: 9610612-2021-00312
• Device Sequence Number: 1
• Product Code: MJO
• UDI-Device Identifier: 04046963143848
• UDI-Public: 4046963143848
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Initial Date Manufacturer Received: 03/23/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 03/17/2022
• Supplement Dates FDA Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention