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

TPLC - Total Product Life Cycle
  • 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
 

New Search show TPLC since Back to Search Results
Device burr, orthopedic
Product CodeHTT
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2014 7 7
2015 17 17
2016 9 9
2017 1 1
2018 2 2
2019 2 2
2020 2 2
2021 2 2
2022 3 3
2023 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 30 30
Detachment Of Device Component 3 3
Corroded 3 3
Overheating of Device 2 2
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 2 2
Bent 2 2
Power Problem 1 1
Insufficient Information 1 1
Physical Resistance/Sticking 1 1
Retraction Problem 1 1
Smoking 1 1
Sticking 1 1
Use of Device Problem 1 1
Metal Shedding Debris 1 1
Component Missing 1 1
Material Discolored 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Patient Involvement 16 16
No Known Impact Or Consequence To Patient 15 15
Insufficient Information 6 6
No Consequences Or Impact To Patient 4 4
No Information 3 3
Burn(s) 2 2
No Clinical Signs, Symptoms or Conditions 1 1
No Code Available 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Linvatec Corp. dba ConMed Linvatec II Sep-08-2009
2 The Anspach Effort, Inc. II May-09-2014
3 The Anspach Effort, Inc. II Feb-04-2013
4 The Anspach Effort, Inc. II Oct-21-2011
5 The Anspach Effort, Inc. II Apr-20-2011
6 Zimmer Gmbh II May-15-2017
-
-