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TPLC
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show TPLC since
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Device
broach
Product Code
HTQ
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
2
2
2016
73
73
2017
225
225
2018
433
433
2019
460
460
2020
466
466
2021
550
550
2022
506
506
2023
586
586
2024
169
169
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device-Device Incompatibility
1279
1279
Break
621
621
Unintended Movement
272
272
Failure to Cut
238
238
Naturally Worn
213
213
Scratched Material
209
209
Material Deformation
205
205
Appropriate Term/Code Not Available
166
166
Loose or Intermittent Connection
133
133
Difficult to Advance
115
115
Material Twisted/Bent
102
102
Adverse Event Without Identified Device or Use Problem
86
86
Connection Problem
83
83
Fracture
80
80
Structural Problem
66
66
Dull, Blunt
51
51
Device Damaged Prior to Use
40
40
Physical Resistance/Sticking
38
38
Mechanical Jam
37
37
Component Missing
35
35
Inadequacy of Device Shape and/or Size
34
34
Material Integrity Problem
33
33
Contamination /Decontamination Problem
33
33
Device Slipped
30
30
Chemical Problem
25
25
No Apparent Adverse Event
25
25
Illegible Information
23
23
Fitting Problem
21
21
Crack
21
21
Bent
20
20
Entrapment of Device
18
18
Difficult to Open or Close
17
17
Insufficient Information
17
17
Mechanical Problem
14
14
Difficult to Remove
13
13
Detachment of Device or Device Component
11
11
Device Dislodged or Dislocated
9
9
Tear, Rip or Hole in Device Packaging
7
7
Defective Device
6
6
Device Contaminated During Manufacture or Shipping
6
6
Device Markings/Labelling Problem
6
6
Positioning Problem
6
6
Device Operates Differently Than Expected
5
5
Difficult to Insert
5
5
Misconnection
4
4
Corroded
4
4
Device Issue
4
4
Off-Label Use
4
4
Device Contamination with Chemical or Other Material
4
4
Incomplete or Inadequate Connection
4
4
Manufacturing, Packaging or Shipping Problem
3
3
Device Damaged by Another Device
3
3
Use of Device Problem
3
3
Failure to Advance
2
2
Disassembly
2
2
Blocked Connection
2
2
Deformation Due to Compressive Stress
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
Compatibility Problem
1
1
Difficult to Open or Remove Packaging Material
1
1
Material Discolored
1
1
Material Disintegration
1
1
Positioning Failure
1
1
Backflow
1
1
Loss of or Failure to Bond
1
1
Difficult To Position
1
1
Material Frayed
1
1
Dent in Material
1
1
Failure to Disconnect
1
1
Malposition of Device
1
1
Solder Joint Fracture
1
1
Sticking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1611
1611
No Consequences Or Impact To Patient
1204
1204
Insufficient Information
203
203
No Code Available
173
173
No Information
147
147
No Known Impact Or Consequence To Patient
135
135
Not Applicable
77
77
Bone Fracture(s)
40
40
Limb Fracture
21
21
Unspecified Tissue Injury
12
12
Pain
10
10
Joint Dislocation
9
9
Unspecified Infection
8
8
No Patient Involvement
7
7
Joint Laxity
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Foreign Body In Patient
3
3
Hip Fracture
2
2
Loss of Range of Motion
2
2
Scar Tissue
1
1
Damage to Ligament(s)
1
1
Nerve Damage
1
1
Low Blood Pressure/ Hypotension
1
1
Fall
1
1
Fatigue
1
1
Foreign Body Reaction
1
1
Deformity/ Disfigurement
1
1
Distress
1
1
Discomfort
1
1
Inadequate Osseointegration
1
1
Device Embedded In Tissue or Plaque
1
1
Thrombosis/Thrombus
1
1
Physical Asymmetry
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Encore Medical, Lp
II
Jul-05-2011
2
Greatbatch Medical
II
May-09-2017
3
Zimmer Inc.
II
Jul-07-2009
4
Zimmer Inc.
II
May-12-2009
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