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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE TRANSCONNECTOR 50-60MM STERILE SPINE SURGERY

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AESCULAP AG ENNOVATE TRANSCONNECTOR 50-60MM STERILE SPINE SURGERY Back to Search Results
Model Number SX950TS
Device Problem Product Quality Problem (1506)
Patient Problem Insufficient Information (4580)
Event Date 11/09/2020
Event Type  malfunction  
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 sx950ts-ennovate trans-connector 50-60mm sterile. According to the complaint description, it was reported that the product had a deviation. Currently no more information available. Additional information was not provided nor available / was not available. Additional patient information is not available. The adverse event / malfunction is filed under aag reference: (b)(4).
 
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Brand NameENNOVATE TRANSCONNECTOR 50-60MM STERILE
Type of DeviceSPINE SURGERY
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 Key10984317
MDR Text Key220768493
Report Number9610612-2020-00870
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K180433
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/03/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSX950TS
Device Catalogue NumberSX950TS
Device Lot Number52507955
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/14/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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