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TPLC
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show TPLC since
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Device
screwdriver
Product Code
HXX
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
2011
2011
2020
1644
1644
2021
2000
2000
2022
1721
1726
2023
1735
1735
2024
294
294
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3486
3486
Material Twisted/Bent
2235
2235
Device-Device Incompatibility
1273
1273
Fracture
704
704
Naturally Worn
547
547
Material Deformation
541
541
Calibration Problem
245
245
Material Integrity Problem
202
202
Contamination /Decontamination Problem
166
166
Entrapment of Device
112
112
Mechanical Jam
86
86
Crack
83
83
Mechanical Problem
82
82
Detachment of Device or Device Component
69
69
Compatibility Problem
66
66
Material Fragmentation
59
59
Connection Problem
55
55
Use of Device Problem
42
42
Packaging Problem
34
34
Unintended Movement
33
33
Appropriate Term/Code Not Available
33
33
Physical Resistance/Sticking
31
31
Component Missing
26
26
Adverse Event Without Identified Device or Use Problem
26
26
Device Slipped
21
21
No Apparent Adverse Event
21
21
Delivered as Unsterile Product
19
19
Device Contamination with Chemical or Other Material
19
19
Defective Device
17
17
Material Separation
17
22
Difficult to Remove
16
16
Scratched Material
14
14
Loose or Intermittent Connection
13
13
Corroded
13
13
Illegible Information
11
11
Dull, Blunt
10
10
Failure to Calibrate
9
9
Device Damaged Prior to Use
9
9
Electrical /Electronic Property Problem
8
8
Material Disintegration
7
7
Fitting Problem
7
7
Manufacturing, Packaging or Shipping Problem
6
6
Device Reprocessing Problem
6
6
Degraded
6
6
Device Difficult to Maintain
6
6
Material Split, Cut or Torn
6
6
Noise, Audible
6
6
Device Handling Problem
5
5
Improper or Incorrect Procedure or Method
5
5
Device Damaged by Another Device
5
5
Activation, Positioning or Separation Problem
5
5
Structural Problem
5
5
Mechanics Altered
4
4
Defective Component
4
4
Insufficient Information
4
4
Incomplete or Inadequate Connection
4
4
Separation Problem
3
3
Failure to Discharge
3
3
Failure to Cut
3
3
Deformation Due to Compressive Stress
3
3
Solder Joint Fracture
2
2
Failure to Disconnect
2
2
Device Sensing Problem
2
2
Labelling, Instructions for Use or Training Problem
2
2
Positioning Failure
2
2
Unstable
2
2
Peeled/Delaminated
2
2
Therapeutic or Diagnostic Output Failure
2
2
Positioning Problem
2
2
Power Problem
2
2
Device Fell
2
2
Sharp Edges
1
1
Patient Device Interaction Problem
1
1
Migration
1
1
Premature Separation
1
1
Unclear Information
1
1
Thickening of Material
1
1
Off-Label Use
1
1
Device Difficult to Program or Calibrate
1
1
Misassembled
1
1
Nonstandard Device
1
1
Shipping Damage or Problem
1
1
Failure to Cycle
1
1
Contamination
1
1
Accessory Incompatible
1
1
Inadequate Instructions for Healthcare Professional
1
1
Difficult to Insert
1
1
Device Markings/Labelling Problem
1
1
Human-Device Interface Problem
1
1
Difficult to Advance
1
1
Device Dislodged or Dislocated
1
1
Output Problem
1
1
Separation Failure
1
1
Difficult or Delayed Activation
1
1
Tear, Rip or Hole in Device Packaging
1
1
Failure to Align
1
1
Dent in Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5466
5471
No Consequences Or Impact To Patient
1837
1837
No Patient Involvement
686
686
No Known Impact Or Consequence To Patient
506
506
Insufficient Information
375
375
Foreign Body In Patient
243
243
No Code Available
200
200
Device Embedded In Tissue or Plaque
92
92
Not Applicable
87
87
No Information
79
79
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Injury
21
21
Failure of Implant
9
9
Unspecified Tissue Injury
9
9
Patient Problem/Medical Problem
8
8
Hemorrhage/Bleeding
5
5
Pain
4
4
Perforation of Vessels
3
3
Blood Loss
3
3
Spinal Cord Injury
2
2
Skull Fracture
2
2
Exsanguination
2
2
Bone Fracture(s)
2
2
Ossification
1
1
Paralysis
1
1
Laceration(s)
1
1
Nerve Damage
1
1
Tissue Damage
1
1
Impaired Healing
1
1
Joint Laxity
1
1
Skin Inflammation/ Irritation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Jul-19-2022
2
Flower Orthopedics Corporation
II
Jun-01-2021
3
Trilliant Surgical, LLC
II
Jan-10-2020
4
Zimmer Biomet, Inc.
II
Jul-04-2019
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