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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG ENNOVATE MULTIAX.CROSS CONN.28-34MM STER SPINE SURGERY

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AESCULAP AG ENNOVATE MULTIAX.CROSS CONN.28-34MM STER SPINE SURGERY Back to Search Results
Model Number SX933TS
Device Problem Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2020
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 sx933ts - ennovate multiax. Cross conn. 28-34mm ster. According to the complaint description, the device was to intense. The product was removed from the pack. First, the nurse tried to loosen the screw, but the screw was so tight and did not loosen. Next, two doctors tried to loosen the screw while holding down the cross connectore, but it still did not loosen. They were able to loosen the screws as they tried to loosen it many times. Finally, it was installed. However, it took more than 5 minutes to install it. This event/malfunction prolonged the surgery. Additional information has been requested but not yet received as of this report. Additional patient information is not available. The adverse event / malfunction is filed under aag reference (b)(4).
 
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Brand NameENNOVATE MULTIAX.CROSS CONN.28-34MM STER
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 Key11014023
MDR Text Key227798091
Report Number9610612-2020-00922
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 02/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSX933TS
Device Catalogue NumberSX933TS
Device Lot Number52490480
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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