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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG AESCULAP010 GENERAL SURGICAL INSTRUMENTS

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AESCULAP AG AESCULAP010 GENERAL SURGICAL INSTRUMENTS Back to Search Results
Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
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 a unknown device manufactured by aesculap ag. According to the complainant, the surgeon reported an adverse event without details about the issue. The type of the indication was an total disc replacement. Although requested, additional information has not been made available. The adverse event / malfunction is filed under aag reference (b)(4). Associated medwatch-reports: 9610612-2021-00542 (article number unknown- aesculap surgical instruments). 9610612-2021-00562 (article number unknown- aesculap surgical instruments). 9610612-2021-00563 (article number unknown- aesculap surgical instruments).
 
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Brand NameAESCULAP010
Type of DeviceGENERAL 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 Key12333524
MDR Text Key266966098
Report Number9610612-2021-00562
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 Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/19/2022
2 Devices were Involved in the Event: 1   2  
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/17/2021 Patient Sequence Number: 1
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