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U.S. Department of Health and Human Services

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

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AESCULAP AG AESCULAP SURGICAL INSTRUMENTS GENERAL SURGICAL INSTRUMENTS Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem 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 on the ess surgeon survey during the reporting period (1feb2020 to 31jan2021) that there was an issue with an active device manufactured by aesculap ag. 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 aic reference (b)(4).

 
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Brand NameAESCULAP SURGICAL INSTRUMENTS
Type of DeviceGENERAL SURGICAL INSTRUMENTS
Manufacturer (Section D)
AESCULAP AG
po box 40
tuttlingen, 78501
GM 78501
MDR Report Key12339351
MDR Text Key267238534
Report Number2916714-2021-00157
Device Sequence Number1
Product Code NKB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation
Type of Report Initial
Report Date 08/18/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/18/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/18/2021
Distributor Facility Aware Date07/20/2021
Event Location Hospital
Date Report TO Manufacturer07/20/2021
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 08/18/2021 Patient Sequence Number: 1
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