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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PARAGON 28, INC. TENOTAC SOFT TISSUE FIXATION SYSTEM
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PARAGON 28, INC. TENOTAC SOFT TISSUE FIXATION SYSTEM Back to Search Results
Model Number P42-022-0065
Device Problem Loose or Intermittent Connection (1371)
Patient Problem Insufficient Information (4580)
Event Date 12/16/2019
Event Type  Injury  
Manufacturer Narrative
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 hammertoe correction surgical procedure that utilized paragon 28 tenotac soft tissue fixation system.The tenotac implant was removed post-operatively at 10 weeks because the patient felt the implant platarly.Upon the removal of the implant, the surgeon noted that the implant was loose and the implant removed easily.It was reported that the hammertoe correction was still in good shape.
 
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Brand Name
TENOTAC SOFT TISSUE FIXATION SYSTEM
Type of Device
TENOTAC
Manufacturer (Section D)
PARAGON 28, INC.
14445 grasslands dr.
englewood CO 80112
MDR Report Key10902088
MDR Text Key218215002
Report Number3008650117-2020-00202
Device Sequence Number1
Product Code MBI
Combination Product (y/n)N
PMA/PMN Number
K182898
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/24/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberP42-022-0065
Device Catalogue NumberP42-022-0065
Was Device Available for Evaluation? No
Date Manufacturer Received12/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
P20-535-032S SHORT THREAD SCREW 3.5 X 32.; P50-353-3512 R3CONLOCKING PLATE SCREW 3.5 X 12M.; P50-353-3512 R3CONLOCKING PLATE SCREW 3.5 X 12M.; P50-353-3514 R3CON LOCKING PLATE SCREW, 3.5 X 14M.; P50-353-3516 R3CON LOCKING PLATE SCREW, 3.5 X 16M.; P50-453-3518 R3CON NON-LOCKING PLATE SCREW 3.5 X.; P53-110-R001 LISFRANC, SLANTED-T, 4-HOLE PLATE.
Patient Outcome(s) Required Intervention;
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