MAUDE Adverse Event Report: AESCULAP AG ACTIV L INF.PLATE SIZE L 0/SPIKES; ACTIV L IMPLANTS

Model Number SW990K

Device Problem Compatibility Problem (2960)

Patient Problem Insufficient Information (4580)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

Investigation on going.Additional information/results will be submitted in a supplemental report.

Event Description

It was reported that there was an issue with activl components.The original type of operation was a total disc replacement (tdr).According to the complaint description, the surgeon removed the implants.A revision was necessary.Additional information has been requested but not yet received as of this report.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00718 (b)(4).9610612-2020-00719 (b)(4).Inferior plate.

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results there is capa is not necessary.

Event Description

It was reported that there was an issue with product sw990 - activ l inf.Plate size l 0°/spikes.Additional information: the patient did not have previous surgeries.The original surgery occurred on (b)(6) 2020, and the revision surgery occurred on (b)(6) 2020.The revision was due to the patient still experiencing pain.The bone quality of the patient was good.There were no complication during the revision surgery.The revision treatment was fusion.The noted components are sw990k, sw991k, and sw966.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00718 (b)(4).9610612-2020-00719 (b)(4).

Manufacturer Narrative

Additional information after examination of the affected implant by an external examination laboratory.Stage i analysis is complete for the retrieved device per exponent's internal protocol and standard operating procedure, which were created using astm f561 standard practice for retrieval and analysis of medical devices, and associated tissues and fluids, as a guide.The articulating and backside surfaces of the polyethylene insert had evidence of machining marks and multidirectional scratches.The inferior and superior endplates had evidence of damage consistent with impingement.The polyethylene inlay showed an area of deformation on the articulating surface.Overall, the results of the stage i analysis are consistent with devices having a short implantation time, iatrogenic damage, and impingement.

Event Description

Associated medwatch-reports: 9610612-2020-00717 (400489557 - sw992k); 9610612-2020-00718 (400489627 - sw991k); 9610612-2020-00719 (400489628 - sw966).

• Brand Name: ACTIV L INF.PLATE SIZE L 0/SPIKES
• Type of Device: ACTIV L IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10824178
• MDR Text Key: 216116609
• Report Number: 9610612-2020-00717
• Device Sequence Number: 1
• Product Code: MJO
• Combination Product (y/n): N
• PMA/PMN Number: P120024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SW990K
• Device Catalogue Number: SW990K
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention