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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE MULTIAX.CROSS CONN.45-58MM STER ENNOVATE IMPLANTS

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AESCULAP AG ENNOVATE MULTIAX.CROSS CONN.45-58MM STER ENNOVATE IMPLANTS Back to Search Results
Model Number SX937TS
Device Problem Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2021
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 sx937ts - ennovate multiax. Cross conn. 45-58mm ster. According to the complaint description, after opening the cross connector, when loosening the three screws, one screw on one side of the side was hard and did not loosen. The screwdriver turned, but every joint turned, and only the screw on one side protruded greatly. After that, another new product of the same size was opened and used. This time, all parts were loosened without any problems. The surgery was completed without any problems. Surgeon's comment: "i want you to loosen the screws a little more before sterilization". There was no described patient harm. Additional information was not provided nor available / was not available. The malfunction is filed under aag reference (b)(4).
 
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Brand NameENNOVATE MULTIAX.CROSS CONN.45-58MM STER
Type of DeviceENNOVATE IMPLANTS
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 Key11339145
MDR Text Key253235330
Report Number9610612-2021-00085
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
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 05/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSX937TS
Device Catalogue NumberSX937TS
Device Lot Number52603211
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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