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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. GRAPPLER INTERFERENCE SCREW SYSTEM
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PARAGON 28, INC. GRAPPLER INTERFERENCE SCREW SYSTEM Back to Search Results
Model Number P41-050-1500-S
Device Problem Connection Problem (2900)
Patient Problem Insufficient Information (4580)
Event Date 12/10/2019
Event Type  malfunction  
Manufacturer Narrative
The device history record was reviewed and met all material specifications with no deviation identified.Devices are not expected to be returned for the manufacturer review/investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.
 
Event Description
It was reported that the patient underwent a surgical procedure that utilized paragon 28 sterile 5 x 15mm grappler peek interference screw.The screw did not mate with the 5mm driver.Another implant was used to complete the procedure.No further information was provided by the reporter.
 
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Brand Name
GRAPPLER INTERFERENCE SCREW SYSTEM
Type of Device
INTERFERENCE 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 Key11283263
MDR Text Key232850922
Report Number3008650117-2021-00023
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183690
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberP41-050-1500-S
Device Catalogue NumberP41-050-1500-S
Device Lot Number260421219H
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/16/2019
Initial Date FDA Received02/04/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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