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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. MONSTER SCREW SYSTEM; BONE SCREW
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PARAGON 28, INC. MONSTER SCREW SYSTEM; BONE SCREW Back to Search Results
Model Number P20-125-036S
Device Problems Material Twisted/Bent (2981); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Case information including facility, surgery date(s), or related patient information was not provided by the initial reporter.The device history record was reviewed and met all material specifications with no deviation identified.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
 
Event Description
A paragon 28 mini-monster ø2.5 x 36mm, headed screw, was reported as bent by the complaint initiator.Due to limited information provided by the initiator, potential of harm is based on worst case-scenario for the failure mode, independent of a condition failure.
 
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Brand Name
MONSTER SCREW SYSTEM
Type of Device
BONE SCREW
Manufacturer (Section D)
PARAGON 28, INC.
14445 grasslands dr.
englewood CO 80112
Manufacturer Contact
victoria akinboboye
14445 grasslands dr.
englewood, CO 80112
MDR Report Key11281295
MDR Text Key232851078
Report Number3008650117-2021-00022
Device Sequence Number1
Product Code HWC
Combination Product (y/n)N
PMA/PMN Number
K190568
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberP20-125-036S
Device Catalogue NumberP20-125-036S
Device Lot NumberSS08190
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2019
Date Manufacturer Received11/21/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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