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

Model Number	SW965
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 a 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).Involved components: sw981k - activ l sup.Plate size m 6°/spikes - 52552035.Sw986k - activ l inf.Plate s1 size m 5°/spikes - 52496212.
Additional Manufacturer Narrative
Correction: awareness date for the initial report was 09jul2020.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.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.According to the 8 d report a capa is not necessary.
Event or Problem Description
No updates.

• 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: 10380788
• Report Number: 9610612-2020-00344
• Device Sequence Number: 14245014
• Product Code: MJO
• UDI-Device Identifier: 04038653430949
• UDI-Public: 4038653430949
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P120024
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2020

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
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 09/15/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 10/12/2020
• 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