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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE TRANSCONNECTOR 50-60MM STERILE IMPLANTS POSTERIOR STABILISATION

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AESCULAP AG ENNOVATE TRANSCONNECTOR 50-60MM STERILE IMPLANTS POSTERIOR STABILISATION Back to Search Results
Model Number SX950TS
Device Problems Product Quality Problem (1506); Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2021
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 that there was an issue with sx950ts - ennovate transconnector 50-60mm sterile. According to the complaint description, the connection of the device was not possible. Even after several attempts, the surgeon did not manage to fix the cross connector with the rods. The screw always overtightened. There was another implant available. Surgery delay was extended by approx. 30 min. An additional medical intervention was necessary. Additional information was not provided nor available. Additional patient information is not available. The adverse event is filed under aag reference (b)(4).
 
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Brand NameENNOVATE TRANSCONNECTOR 50-60MM STERILE
Type of DeviceIMPLANTS POSTERIOR STABILISATION
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 Key11619048
MDR Text Key243930698
Report Number9610612-2021-00270
Device Sequence Number1
Product Code NKB
UDI-Device Identifier04046964995712
UDI-Public4046964995712
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 07/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSX950TS
Device Catalogue NumberSX950TS
Device Lot Number52581399
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/06/2021 Patient Sequence Number: 1
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