Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLOWER ORTHOPEDICS VARIABLE ANGLE LOCKING PEG, D: 1.8MM X L: 20.0MM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

FLOWER ORTHOPEDICS VARIABLE ANGLE LOCKING PEG, D: 1.8MM X L: 20.0MM Back to Search Results
Model Number FDR 120
Medical Device Problem Codes Nonstandard Device (1420); Product Quality Problem (1506); Device Issue (2379)
Health Effect - Clinical Code No Information (3190)
Date of Event 04/27/2017
Type of Reportable Event Malfunction
Event or Problem Description
Locking peg (fdr 120, lot 1611320064) went through distal radius plate (fdr 011, lot 2014003534).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
VARIABLE ANGLE LOCKING PEG, D: 1.8MM X L: 20.0MM
Common Device Name
LOCKING PEG
Manufacturer (Section D)
FLOWER ORTHOPEDICS
100 witmer rd
suite 280
horsham PA 19044
MDR Report Key6552956
Report Number3009996260-2017-00004
Device Sequence Number11011628
Product Code HWC
UDI-Device Identifier00840118110884
UDI-Public840118110884
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K123562
Number of Events Summarized1
Summary Report (Y/N)N
Device Explanted Year2017
Reporter Type Manufacturer
Report Source company representative,user f
Initial Reporter Occupation Medical Equipment Company Technician/Representative
Remedial Action Inspection,Notification
Type of Report Initial
Report Date (Section B) 05/08/2017
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
Operator of Device Physician
Device Expiration Date10/31/2023
Device Model NumberFDR 120
Device Lot Number1611320064
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2017
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/05/2017
Initial Report FDA Received Date05/08/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age25 YR
-
-