MAUDE Adverse Event Report: AESCULAP AG ACTIV L PE-INLAY 8.5MM; ACTIV L IMPLANTS

Model Number	SW965
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Osseointegration (2646); No Code Available (3191)
Date of Event	07/08/2020
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 an activ l pe-inlay 8.5mm, an activ l sup.Plate size m 6°/spikes (reference mdr id 2916714-2020-00283, and an activ l inf.Plate s1 size m 5°/spikes (reference mdr id 2916714-2020-00282), for an active l prosthetic disc implant.According to the complaint description the implant migrated 8 weeks postoperative.The implant migrated anteriorly.No issues on two week postoperative x-ray images and no issues in the surgery.A revision surgery was necessary.Additional information has been requested but not yet received as of this report.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Associated medwatches: 2916714-2020-00282, 2916714-2020-00283, 2916714-2020-00284.Reference code sw965.Device name activ l pe-inlay 8.5mm.Serial number n/a.Batch number 52556405.Udi device identifier (b)(4).Udi production identifier (b)(4) basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date 11.10.2019.Reference code sw986k.Device name activ l inf.Plate s1 size m 5°/spikes.Serial number n/a.Batch number 52496212.Udi device identifier (b)(4).Udi production identifier (b)(4).Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date 13.05.2019.Reference code sw981k.Device name activ l sup.Plate size m 6°/spikes serial number n/a batch number 52552035 udi device identifier (b)(4).Udi production identifier (b)(4).Basic udi-di n/a.Unit of use udi-di (b)(4).Manufacturing date 02.01.2020.Investigation: no product at hand.Pictorial documentation: no product at hand.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There is one similar complaint against lot number 52556405 (sw965) at hand.Explanation and rationale: due to the circumstances we did not receive any devices for investigation and the lack of information it is not possible to determine a definitive conclusion and root cause for this failure.Conclusion and root cause: due to the current deviation and according to the rationale, the root cause of the problem is most probably patient and usage related.Because there are no products and only minor information available, a definitive root cause analysis is not possible.Following causes are possible: wrong system configuration selected by the user, wrong implant size chosen by the user, design layout unsuitable, inadequate patient behavior, maybe implant not in the correct position, not the correct system for the purpose.Corrective action: according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa necessary.
Event or Problem Description
No updates.
Additional Manufacturer Narrative
Correction: awareness date for the initial report was 09jul2020.This follow-up medwatch is being submitted as follow-up #2; #1 was rejected in webtrader as a duplicate supplemental (however, the mdr number was unique to this complaint).Associated medwatches: 2916714-2020-00282, 2916714-2020-00283, 2916714-2020-00284.Reference code: sw965; device name activ l pe-inlay 8.5mm; serial number n/a; batch number 52556405; udi device identifier (b)(4); udi production identifier (b)(4); basic udi-di n/a; unit of use udi-di (b)(4); manufacturing date 11.10.2019.Reference code sw986k; device name activ l inf.Plate s1 size m 5°/spikes; serial number n/a; batch number 52496212; udi device identifier (b)(4); udi production identifier (b)(4); basic udi-di n/a; unit of use udi-di (b)(4); manufacturing date 13.05.2019.Reference code sw981k; device name activ l sup.Plate size m 6°/spikes; serial number n/a; batch number 52552035; udi device identifier (b)(4); udi production identifier (b)(4); basic udi-di n/a; unit of use udi-di (b)(4); manufacturing date 02.01.2020.Investigation no product at hand.Pictorial documentation no product at hand.Batch history review: the device quality and manufacturing history records (dhr) have been checked for all available lot numbers and the products found to be according to our specification valid at the time of production.There is one similar complaint against lot number 52556405 (sw965) at hand.Explanation and rationale: due to the circumstances we did not receive any devices for investigation and the lack of information it is not possible to determine a definitive conclusion and root cause for this failure.Conclusion and root cause: due to the current deviation and according to the rationale, the root cause of the problem is most probably patient and usage related.Because there are no products and only minor information available, a definitive root cause analysis is not possible.Following causes are possible: wrong system configuration selected by the user, wrong implant size chosen by the user, design layout unsuitable, inadequate patient behavior, maybe implant not in the correct position, not the correct system for the purpose.Corrective action: according to sa-de13-m-4-2-04-000-0 (corrective action & preventive action) there is no capa necessary.
Event or Problem Description
No updates.

• Brand Name: ACTIV L PE-INLAY 8.5MM
• Common Device Name: ACTIV L IMPLANTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10380836
• Report Number: 2916714-2020-00284
• Device Sequence Number: 3146333
• Product Code: MJO
• UDI-Device Identifier: 04038653430949
• UDI-Public: 4038653430949
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/30/2020

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: 10/10/2024
• Device Model Number: SW965
• Device Catalogue Number: SW965
• Device Lot Number: 52556405
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/15/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 09/30/2020; 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SW981K - LOT 52552035.; SW986K - LOT 52496212.
• Outcome Attributed to Adverse Event: Required Intervention