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

Model Number	SW965
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	06/26/2020
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 the product activ l pe-inlay 8.5mm.The original surgery was a total disc replacement (tdr).Specifically, it was reported that there was an anterior migration of implants 6 months post operation.A revision surgery was performed by a different neurosurgeon.Activl components were removed and posterior pedicle screws (competitor product) were placed.Additional information has been requested.The adverse event / malfunction is filed under reference (b)(4).Associated medwatch-reports: 2916714-2020-00235.2916714-2020-00245.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation no product at hand.Internal notification number: (b)(4), device 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 31.10.2019.Reference code sw981k, device name activ l sup.Plate size m 6°/spikes, serial number n/a, batch number 52434149, udi device identifier (b)(4), udi production identifier (b)(4), basic udi-di n/a, unit of use udi-di (b)(4).Manufacturing date 03.08.2018.Reference code sw986k, device name activ l inf.Plate s1 size m 5°/spikes, serial number n/a, batch number 52350235, udi device identifier (b)(4), udi production identifier (b)(4), basic udi-di n/a, unit of use udi-di (b)(4), manufacturing date 18.10.2017.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 are no similar complaints against the lot number 52434149 (sw981k) with this error pattern.There is one similar complaint against the same lot number(s) 52556405 (sw965); 52350235 (sw986k).Explanation and rationale: due to the circumstances we do 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 4.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.Associated medwatch-reports: 2916714-2020-00235, 2916714-2020-00244, 2916714-2020-00245.
Additional Manufacturer Narrative
Investigation results: according of the analysis report of an external institute: all retrieved device components (superior endplate, polyethylene inlay, and inferior endplate) were examined macroscopically for signs of wear, iatrogenic damage, and impingement.The polyethylene inlay and inferior endplate showed signs of iatrogenic damage.The backside surface of the superior and inferior endplates had remnants of bone.The superior and inferior endplates and polyethylene inlay had evidence of damage consistent with impingement.Mating marks consistent with impingement were observed on the components.Machining marks and multidirectional scratches were observed on the articulating and backside surfaces of the polyethylene inlay.The articulating surface of the polyethylene inserts had evidence of machining marks and multidirectional scratches.All three components had evidence of damage consistent with impingement.Overall, the results of the stage i analysis are consistent with devices having a short implantation time, iatrogenic damage, and impingement.
Event or Problem Description
No updates.Associated medwatch-reports: 2916714-2020-00235 and 2916714-2020-00245.
Event or Problem Description
Updates: additional data: level l5/s1.Gender: male.Implantation date: (b)(6) 2019.(implantation time 0.5 years).Explantation date: (b)(6) 2020.Reason for removal: severe back pain and right leg pain.Associated medwatch-reports: 2916714-2020-00235.2916714-2020-00244.2916714-2020-00245.
Additional Manufacturer Narrative
Updates: a.Gender.B5.Description.D6.Implant and explant dates.F10.Health effect code.Associated medwatch-reports: 2916714-2020-00235.2916714-2020-00244.2916714-2020-00245.

• Brand Name: ACTIV L PE-INLAY 8.5MM
• Common Device Name: IMPLANTS SPINAL MOTION
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10266519
• Report Number: 2916714-2020-00244
• Device Sequence Number: 3044620
• Product Code: MJO
• UDI-Device Identifier: 04038653430949
• UDI-Public: 4038653430949
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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,Followup,Followup
• Report Date (Section B): 03/11/2021
• Report Date (Section F): 07/13/2020

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?: Yes
• Distributor Facility Aware Date: 02/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 07/13/2020
• Supplement Report FDA Received Date: 09/15/2020; 02/04/2021; 03/11/2021
• 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
• Date Report Sent to FDA: 07/13/2020