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

Model Number AE-QAS-SP42

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Type  Injury  

Manufacturer Narrative

Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.

Event Description

It was reported that there was an issue with aesculap010 - aesculap surgical instruments.According to the complaint description, the surgeon reported an adverse event without details about the issue.The type of indication was total disc replacement.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: ((b)(4) - aesculap010), 9610612-2021-00559 ((b)(4) - aesculap010), 9610612-2021-00560 ((b)(4) - aesculap010).

Manufacturer Narrative

Associated medwatch reports: 9610612-2021-00543.9610612-2021-00559.9610612-2021-00560.Investigation: up to now, products not provided.Therefore, no investigation possible.Batch history review: due to the fact that neither an article nor a lot number was provided, a review of the device history records must remain incomplete.Explanation and rationale/conclusion and root cause: because there are no products and only minor information available, a definitive root cause analysis is not possible.Because the device history record is without any deviation, a material defect or manufacturing failure can be excluded.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.Corrective action: a capa is not necessary.

Event Description

Update: the information was received via a surgeon survey for activl products, for the reporting period (b)(6) 2020-(b)(6) 2021.The leading material was not specified: ae-qas-sp42 - collect.No.Qas spine anterior stabilis was selected.

• 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: 12334150
• MDR Text Key: 267049130
• Report Number: 9610612-2021-00543
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AE-QAS-SP42
• Device Catalogue Number: AE-QAS-SP42
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• 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