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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. APEX 3D TOTAL ANKLE REPLACEMENT SYSTEM; APEX 3D-PS TOTAL ANKLE REPLACEMENT SYSTEM, POLY INSERTION TOOL
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PARAGON 28, INC. APEX 3D TOTAL ANKLE REPLACEMENT SYSTEM; APEX 3D-PS TOTAL ANKLE REPLACEMENT SYSTEM, POLY INSERTION TOOL Back to Search Results
Model Number P10-951-IN02
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2022
Event Type  malfunction  
Event Description
Device was found broken during a case.The device was not used in surgery however, the device failure could have hindered successful placement of an implant.
 
Manufacturer Narrative
(b)(4).This complaint was not escalated to root cause analysis.
 
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Brand Name
APEX 3D TOTAL ANKLE REPLACEMENT SYSTEM
Type of Device
APEX 3D-PS TOTAL ANKLE REPLACEMENT SYSTEM, POLY INSERTION TOOL
Manufacturer (Section D)
PARAGON 28, INC.
14445 grasslands dr.
englewood CO 80112
Manufacturer Contact
victoria akinboboye
14445 grasslands dr.
englewood, CO 80112
7207165439
MDR Report Key15717356
MDR Text Key303306159
Report Number3008650117-2022-00129
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192994
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 11/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberP10-951-IN02
Device Catalogue NumberP10-951-IN02
Device Lot NumberMG2005009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/14/2022
Initial Date Manufacturer Received 09/06/2022
Initial Date FDA Received11/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/12/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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