Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
broach
Product Code
HTQ
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
433
433
2019
460
460
2020
466
466
2021
550
550
2022
506
506
2023
121
121
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device-Device Incompatibility
898
898
Break
399
399
Failure to Cut
210
210
Scratched Material
191
191
Unintended Movement
189
189
Naturally Worn
162
162
Material Deformation
155
155
Difficult to Advance
113
113
Loose or Intermittent Connection
113
113
Material Twisted/Bent
102
102
Appropriate Term/Code Not Available
81
81
Adverse Event Without Identified Device or Use Problem
76
76
Fracture
58
58
Connection Problem
56
56
Dull, Blunt
50
50
Structural Problem
48
48
Physical Resistance/Sticking
38
38
Component Missing
35
35
Inadequacy of Device Shape and/or Size
33
33
Mechanical Jam
33
33
Device Slipped
29
29
Contamination /Decontamination Problem
28
28
Material Integrity Problem
24
24
Illegible Information
21
21
Crack
18
18
Entrapment of Device
17
17
Difficult to Open or Close
16
16
Fitting Problem
15
15
Device Damaged Prior to Use
14
14
Chemical Problem
14
14
Difficult to Remove
12
12
Bent
10
10
Tear, Rip or Hole in Device Packaging
6
6
Defective Device
6
6
Device Markings/Labelling Problem
6
6
Device Dislodged or Dislocated
6
6
Positioning Problem
6
6
Insufficient Information
6
6
Detachment of Device or Device Component
5
5
Difficult to Insert
5
5
Device Contamination with Chemical or Other Material
4
4
Device Contaminated During Manufacture or Shipping
4
4
Incomplete or Inadequate Connection
4
4
No Apparent Adverse Event
3
3
Device Damaged by Another Device
3
3
Use of Device Problem
3
3
Device Issue
3
3
Blocked Connection
2
2
Deformation Due to Compressive Stress
2
2
Failure to Advance
2
2
Mechanical Problem
2
2
Off-Label Use
2
2
Corroded
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Device Operates Differently Than Expected
2
2
Separation Problem
2
2
Failure to Clean Adequately
1
1
Noise, Audible
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Migration
1
1
Output Problem
1
1
Difficult to Open or Remove Packaging Material
1
1
Backflow
1
1
Loss of or Failure to Bond
1
1
Positioning Failure
1
1
Material Discolored
1
1
Material Frayed
1
1
Sticking
1
1
Misconnection
1
1
Dent in Material
1
1
Failure to Disconnect
1
1
Solder Joint Fracture
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
1129
1129
No Clinical Signs, Symptoms or Conditions
1078
1078
No Code Available
169
169
Insufficient Information
104
104
Not Applicable
76
76
Bone Fracture(s)
38
38
No Known Impact Or Consequence To Patient
34
34
Limb Fracture
16
16
No Information
11
11
Unspecified Tissue Injury
10
10
Pain
8
8
Joint Dislocation
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Foreign Body In Patient
4
4
Joint Laxity
4
4
No Patient Involvement
4
4
Unspecified Infection
4
4
Damage to Ligament(s)
1
1
Nerve Damage
1
1
Distress
1
1
Discomfort
1
1
Deformity/ Disfigurement
1
1
Inadequate Osseointegration
1
1
Scar Tissue
1
1
Device Embedded In Tissue or Plaque
1
1
Thrombosis/Thrombus
1
1
-
-