MAUDE Adverse Event Report: AESCULAP AG AESCULAP SURGICAL INSTRUMENTS; GENERAL SURGICAL INSTRUMENTS

Model Number AESCULAP010

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Failure of Implant (1924)

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 to aesculap inc.On an ess surgeon activel survery (reporting during the time frame 1feb2020 to 31jan2021), unspecified activel spine implant was used during a total disc replacement (tdr) procedure performed on an unknown date.According to the complaint description, the surgeon reported an adverse event without details about the issue.Additional information was not provided.Additional patient information is not available.The adverse event is filed under (b)(4) reference (b)(4).Associated medwatch-reports: 9610612-2021-00544 ((b)(4) - ae-qas-sp42).9610612-2021-00557 ((b)(4) - ae-qas-sp42).9610612-2021-00558 ((b)(4) - aesculap010).

Manufacturer Narrative

Corrected information - b1.Associated medwatch reports: 9610612-2021-00544.9610612-2021-00557.9610612-2021-00558.Investigation: 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 - due to the fact that neither an article number nor a lot number was provided, a review of the device history records must remain incomplete.Conclusion and measures / preventive measures: 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.-end plate formed too strong by the user.- design layout unsuitable.- inadequate patient behaviour.Based upon the investigations results a capa is not necessary.

• Brand Name: AESCULAP SURGICAL INSTRUMENTS
• Type of Device: GENERAL SURGICAL INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12336556
• MDR Text Key: 267070691
• Report Number: 9610612-2021-00558
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AESCULAP010
• Device Catalogue Number: AESCULAP010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other