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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
2017
225
225
2018
433
433
2019
460
460
2020
466
466
2021
550
550
2022
298
298
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device-Device Incompatibility
759
759
Break
419
419
Scratched Material
162
162
Appropriate Term/Code Not Available
160
160
Unintended Movement
144
144
Failure to Cut
143
143
Material Deformation
137
137
Naturally Worn
129
129
Loose or Intermittent Connection
128
128
Material Twisted/Bent
102
102
Difficult to Advance
88
88
Connection Problem
82
82
Adverse Event Without Identified Device or Use Problem
68
68
Fracture
65
65
Dull, Blunt
51
51
Structural Problem
43
43
Physical Resistance/Sticking
38
38
Component Missing
35
35
Inadequacy of Device Shape and/or Size
34
34
Device Slipped
30
30
Mechanical Jam
29
29
Contamination /Decontamination Problem
27
27
Crack
20
20
Illegible Information
19
19
Fitting Problem
18
18
Bent
16
16
Entrapment of Device
14
14
Material Integrity Problem
14
14
Difficult to Remove
13
13
Device Damaged Prior to Use
12
12
Insufficient Information
12
12
Chemical Problem
11
11
Difficult to Open or Close
11
11
Device Dislodged or Dislocated
6
6
Device Markings/Labelling Problem
6
6
Positioning Problem
6
6
Defective Device
6
6
Mechanical Problem
6
6
Difficult to Insert
5
5
Incomplete or Inadequate Connection
4
4
Device Operates Differently Than Expected
4
4
Device Contamination with Chemical or Other Material
4
4
Device Damaged by Another Device
3
3
Detachment of Device or Device Component
3
3
Use of Device Problem
3
3
Device Issue
3
3
Misconnection
3
3
Corroded
2
2
Disassembly
2
2
Blocked Connection
2
2
Deformation Due to Compressive Stress
2
2
Failure to Advance
2
2
Off-Label Use
2
2
Tear, Rip or Hole in Device Packaging
2
2
Device Contaminated During Manufacture or Shipping
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Separation Problem
2
2
Failure to Clean Adequately
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Migration
1
1
Compatibility Problem
1
1
Difficult to Open or Remove Packaging Material
1
1
Sticking
1
1
Solder Joint Fracture
1
1
Dent in Material
1
1
Failure to Disconnect
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
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
1188
1188
No Clinical Signs, Symptoms or Conditions
778
778
No Code Available
172
172
No Information
131
131
No Known Impact Or Consequence To Patient
94
94
Insufficient Information
88
88
Not Applicable
77
77
Bone Fracture(s)
36
36
Limb Fracture
10
10
Unspecified Tissue Injury
9
9
Pain
7
7
Joint Dislocation
6
6
No Patient Involvement
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Joint Laxity
3
3
Unspecified Infection
3
3
Hip Fracture
2
2
Discomfort
1
1
Damage to Ligament(s)
1
1
Nerve Damage
1
1
Inadequate Osseointegration
1
1
Foreign Body In Patient
1
1
Device Embedded In Tissue or Plaque
1
1
Thrombosis/Thrombus
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Greatbatch Medical
II
May-09-2017
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