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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 4WEB, INC. 4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE STRAIGHT PUNCH AWL

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4WEB, INC. 4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE STRAIGHT PUNCH AWL Back to Search Results
Model Number ASTS-SA-100006
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2021
Event Type  malfunction  
Manufacturer Narrative
The broken awl was returned to the manufacturer and analyzed. Production records were reviewed and no manufacturing deficiences were identified that could have contributed to this event.
 
Event Description
The tip of the straight punch awl used in surgery broke in the screw hole of the 4web anterior cage. It was reported that the anti-backout plate was engaged, however, due to the tip breaking, one of the three screws could not be implanted with the cage. The tip of the instrument was left in the patient since it could not be retrieved. Surgery was completed successfully.
 
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Brand Name4WEB ANTERIOR SPINE TRUSS SYSTEM - STAND ALONE
Type of DeviceSTRAIGHT PUNCH AWL
Manufacturer (Section D)
4WEB, INC.
2801 network boulevard
suite 620
frisco TX 75034
Manufacturer (Section G)
4WEB, INC.
2801 network boulevard
suite 620
frisco TX 75034
Manufacturer Contact
upasana veturi
2801 network boulevard
suite 620
frisco, TX 75034
8002857090
MDR Report Key12510015
MDR Text Key273746366
Report Number3009189869-2021-00005
Device Sequence Number1
Product Code HWJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberASTS-SA-100006
Device Catalogue NumberASTS-SA-100006
Device Lot Number30394
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/11/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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