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

Model Number	SW965
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Pain (1994); Joint Disorder (2373); Insufficient Information (4580)
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.Specifically, it was reported that there was an anterior migration of implants 6 months post operation.A revision surgery was necessary.Additional information has been requested.The adverse event / malfunction is filed under aag reference (b)(4) ((b)(4)).Associated medwatch-reports: 9610612-2020-00287 (400477177 / sw981k).9610612-2020-00288 (400477178 / sw986k).
Additional Manufacturer Narrative
Additional information received on 02 juli2020.The operation report is not provided, the implant activ l was removed and posterior pedicle screws from a competitor were placed.They have one image of the 6 month post -op lateral, its shows slight subsidence of the superior plate.Unfortunately, this patient had not gone back to an activl trained surgeon.Associated medwatch-reports: 9610612-2020-00287 (400477177 / sw981k), 9610612-2020-00288 (400477178 / sw986k).
Additional Manufacturer Narrative
Investigation results: to date there is no device available for investigation.The device history records have been checked for all available lot numbers and found to be according to the specification, valid at the time of production.There are no further complaints registered against the same lot numbers.On the basis of the current information and without the product for investigation, a clear conclusion can not be drawn.There is no indication for a material defect or manufacturing failure on the basis of the device history records.A capa is not necessary.
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
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: 9610612-2020-00287 (400477177/sw981k); 9610612-2020-00288 (400477178/sw986k).

• 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: 10240973
• Report Number: 9610612-2020-00286
• Device Sequence Number: 16752222
• Product Code: MJO
• UDI-Device Identifier: 04038653430949
• UDI-Public: 4038653430949
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/11/2021

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
• Initial Date Received by Manufacturer: 06/26/2020
• Supplement Date Received by Manufacturer: 07/02/2020; 09/09/2020; 02/12/2021
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 07/22/2020; 10/07/2020; 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