MAUDE Adverse Event Report: AESCULAP AG ACTIV L PE-INLAY 8.5MM; PROSTHESIS, INTERVERTEBRAL DISC

Model Number SW965

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 12/15/2020

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 sw965 - activ l pe-inlay 8.5mm.According to the complaint description, the activl implant migrated 4 months after surgery.Original surgery was (b)(6) 2020; the procedure was a total disc replacement (tdr).Patient was on vacation and did "something in ocean".Implant was removed and patient fused (b)(6) 2020.A revision surgery was necessary.Additional information was not provided nor available / was not available.The adverse event / malfunction is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00956 ((b)(4) sw972k), 9610612-2020-00962 ((b)(4) sw970k).

Manufacturer Narrative

Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that no similar complaints have been filed against products from this batch number.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results there is capa is not necessary.

Event Description

Associated medwatch-reports: 9610612-2020-00956 ((b)(4) sw972k).9610612-2020-00957 ((b)(4) sw965).9610612-2020-00962 ((b)(4) sw970k).

• Brand Name: ACTIV L PE-INLAY 8.5MM
• Type of Device: PROSTHESIS, INTERVERTEBRAL DISC
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11127337
• MDR Text Key: 226060232
• Report Number: 9610612-2020-00957
• 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
• Report Date: 03/12/2021

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
• Device Operator: Health Professional
• Device Model Number: SW965
• Device Catalogue Number: SW965
• Device Lot Number: 52584212
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2020
• Initial Date FDA Received: 01/06/2021
• Supplement Dates Manufacturer Received: 02/12/2021
• Supplement Dates FDA Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR