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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. HAMMERTUBE SYSTEM; HAMMERTUBE IMPLANT, 2.75MM, 10° CANNULATED STERILE
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PARAGON 28, INC. HAMMERTUBE SYSTEM; HAMMERTUBE IMPLANT, 2.75MM, 10° CANNULATED STERILE Back to Search Results
Model Number P40-002-0275-S
Device Problems Product Quality Problem (1506); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/20/2022
Event Type  malfunction  
Event Description
Nonconforming products were found in a case where the titanium plasma coating was missing on implants.No patient impact was reported and the implants were not used.
 
Manufacturer Narrative
Referencing ra22-03.
 
Manufacturer Narrative
Changed medical device problem code from 3190 to 1506.
 
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Brand Name
HAMMERTUBE SYSTEM
Type of Device
HAMMERTUBE IMPLANT, 2.75MM, 10° CANNULATED STERILE
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 Key15240656
MDR Text Key299693149
Report Number3008650117-2022-00066
Device Sequence Number1
Product Code HTY
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K171715
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
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 Model NumberP40-002-0275-S
Device Catalogue NumberP40-002-0275-S
Device Lot Number26010822202
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/20/2022
Initial Date FDA Received08/17/2022
Supplement Dates Manufacturer Received05/20/2022
Supplement Dates FDA Received11/02/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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