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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC PHANTOM HINDFOOT TTC/TC NAIL SYSTEM SLAP HAMMER

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PARAGON 28, INC PHANTOM HINDFOOT TTC/TC NAIL SYSTEM SLAP HAMMER Back to Search Results
Model Number P99-150-2002
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Date 09/15/2021
Event Type  malfunction  
Event Description
Threading issue with the slap hammer delayed surgery 45 minutes; limited information.
 
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Brand NamePHANTOM HINDFOOT TTC/TC NAIL SYSTEM
Type of DeviceSLAP HAMMER
Manufacturer (Section D)
PARAGON 28, INC
14445 grasslands dr
englewood CO 80112
Manufacturer Contact
jenny conger
14445 grasslands dr
englewood, CO 80112
MDR Report Key12582757
MDR Text Key276362459
Report Number3008650117-2021-00117
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K201227
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberP99-150-2002
Device Catalogue NumberP99-150-2002
Device Lot Number9156883
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/27/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
Was Device Evaluated by Manufacturer? Yes
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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