MAUDE Adverse Event Report: AESCULAP AG ACTIV L IMPLANT KIT; SPINE SURGERY

Model Number LSET-AU-ACTIVL-IMP

Device Problem Migration (4003)

Patient Problems Erosion (1750); Joint Disorder (2373)

Event Date 06/08/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with activ l implant kit.According to the customer description, after a total disc replacement (tdr), there was anterior migration of the implant 6 months postoperatively.It was reported that the revision surgery is scheduled for (b)(6) 2020.Additional information was received on 16 jun 2020, that the surgeon was not able to achieve anterior access to the migrated implant and therefore left the implant intact and locked down with a posterior fusion.Competitor parts, screws, were used to lock down posterior.Additional information such as the operative report and x-rays are not available.The adverse event / malfunction is filed under aag reference (b)(4).

Manufacturer Narrative

Investigation results: the devices were not available for investigation.Therefore neither the article code nor a lot number was provided.A review of the device history records must remain incomplete due to a lack of information.As well a definitive root cause cannot be determined due to the same circumstances.A investigation was not possible without a article return or further information.

Event Description

Associated medwatch-reports: 9610612-2020-00228 (400474862) 9610612-2020-00404 (400480755) 9610612-2020-00403 (400480756).

Manufacturer Narrative

Additional information received: the article number changed to collect.No.Qas spine anterior stabilis.Addtional two cc cases was created.9610612-2020-00404 ((b)(4) ae-qas-sp42); 9610612-2020-00403 ((b)(4) ae-qas-sp42).

• Brand Name: ACTIV L IMPLANT KIT
• Type of Device: SPINE SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10184685
• MDR Text Key: 201180097
• Report Number: 9610612-2020-00228
• 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: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LSET-AU-ACTIVL-IMP
• Device Catalogue Number: LSET-AU-ACTIVL-IMP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR