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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AESCULAP AG S4 ELEMENT MIS POLYAXIAL SCREW 6.5X40MM S4 ELEMENT IMPLANTS

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AESCULAP AG S4 ELEMENT MIS POLYAXIAL SCREW 6.5X40MM S4 ELEMENT IMPLANTS Back to Search Results
Model Number ST063T
Device Problem Fitting Problem (2183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
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 st063t - s4 element mis polyaxial screw 6. 5x40mm. According to the complaint description, the surgeon found the screw nail and head couldn't be fitting tightly when just open the box. Sample is available for investigation. There was no described patient harm. Additional information was not provided nor available / was not available. The malfunction is filed under (b)(4).
 
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Brand NameS4 ELEMENT MIS POLYAXIAL SCREW 6.5X40MM
Type of DeviceS4 ELEMENT 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 Key11400024
MDR Text Key249478348
Report Number9610612-2021-00193
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeTW
PMA/PMN Number
K090657
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberST063T
Device Catalogue NumberST063T
Device Lot Number52603804
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2020
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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