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TPLC
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Device
broach
Product Code
HTQ
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
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
301
301
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device-Device Incompatibility
1363
1363
Break
644
644
Unintended Movement
294
294
Failure to Cut
238
238
Naturally Worn
224
224
Material Deformation
221
221
Scratched Material
215
215
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
88
88
Connection Problem
83
83
Fracture
81
81
Structural Problem
67
67
Dull, Blunt
51
51
Device Damaged Prior to Use
44
44
Physical Resistance/Sticking
38
38
Mechanical Jam
37
37
Material Integrity Problem
35
35
Component Missing
35
35
Inadequacy of Device Shape and/or Size
34
34
Contamination /Decontamination Problem
33
33
Device Slipped
30
30
Chemical Problem
28
28
No Apparent Adverse Event
26
26
Illegible Information
24
24
Crack
22
22
Fitting Problem
21
21
Bent
20
20
Entrapment of Device
18
18
Difficult to Open or Close
17
17
Insufficient Information
16
16
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
Positioning Problem
6
6
Device Markings/Labelling Problem
6
6
Defective Device
6
6
Device Contaminated During Manufacture or Shipping
6
6
Difficult to Insert
5
5
Device Operates Differently Than Expected
5
5
Device Issue
4
4
Corroded
4
4
Misconnection
4
4
Off-Label Use
4
4
Incomplete or Inadequate Connection
4
4
Device Contamination with Chemical or Other Material
4
4
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1687
1687
No Consequences Or Impact To Patient
1204
1204
Insufficient Information
258
258
No Code Available
173
173
No Information
147
147
No Known Impact Or Consequence To Patient
134
134
Not Applicable
77
77
Bone Fracture(s)
39
39
Limb Fracture
23
23
Unspecified Tissue Injury
14
14
Pain
11
11
Joint Dislocation
9
9
Unspecified Infection
8
8
No Patient Involvement
7
7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Joint Laxity
5
5
Foreign Body In Patient
3
3
Hip Fracture
2
2
Loss of Range of Motion
2
2
Damage to Ligament(s)
1
1
Inadequate Osseointegration
1
1
Fatigue
1
1
Foreign Body Reaction
1
1
Thrombosis/Thrombus
1
1
Discomfort
1
1
Nerve Damage
1
1
Scar Tissue
1
1
Fall
1
1
Physical Asymmetry
1
1
Deformity/ Disfigurement
1
1
Low Blood Pressure/ Hypotension
1
1
Device Embedded In Tissue or Plaque
1
1
Distress
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Greatbatch Medical
II
May-09-2017
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