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TPLC
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show TPLC since
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Device
bit, drill
Product Code
HTW
Regulation Number
888.4540
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
1211
1211
2020
1245
1245
2021
1569
1569
2022
1519
1519
2023
1771
1771
2024
228
228
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
4122
4122
Failure to Cut
952
952
Entrapment of Device
675
675
Material Deformation
575
575
Device-Device Incompatibility
549
549
Fracture
486
486
Material Twisted/Bent
334
334
Naturally Worn
241
241
Dull, Blunt
190
190
Mechanical Jam
86
86
Material Integrity Problem
76
76
Contamination /Decontamination Problem
60
60
Adverse Event Without Identified Device or Use Problem
48
48
Physical Resistance/Sticking
41
41
Illegible Information
37
37
Material Fragmentation
35
35
Detachment of Device or Device Component
34
34
No Apparent Adverse Event
31
31
Corroded
27
27
Appropriate Term/Code Not Available
27
27
Degraded
24
24
Scratched Material
20
20
Difficult to Remove
19
19
Improper or Incorrect Procedure or Method
16
16
Component Missing
15
15
Use of Device Problem
15
15
Material Separation
15
15
Crack
14
14
Device Contaminated During Manufacture or Shipping
14
14
Unintended Movement
13
13
Overheating of Device
12
12
Packaging Problem
11
11
Structural Problem
10
10
Mechanical Problem
10
10
Insufficient Information
9
9
Manufacturing, Packaging or Shipping Problem
6
6
Separation Failure
6
6
Difficult to Insert
6
6
Device Contamination with Chemical or Other Material
6
6
Patient Device Interaction Problem
5
5
Flaked
5
5
Delivered as Unsterile Product
4
4
Tear, Rip or Hole in Device Packaging
4
4
Smoking
4
4
Device Markings/Labelling Problem
4
4
Failure to Align
4
4
Material Split, Cut or Torn
4
4
Device Handling Problem
3
3
Inaccurate Information
3
3
Failure to Advance
3
3
Difficult to Advance
3
3
Temperature Problem
3
3
Therapeutic or Diagnostic Output Failure
3
3
Device Slipped
3
3
Product Quality Problem
3
3
Labelling, Instructions for Use or Training Problem
2
2
Melted
2
2
Nonstandard Device
2
2
Loss of or Failure to Bond
2
2
Material Disintegration
2
2
Device Difficult to Maintain
2
2
Deformation Due to Compressive Stress
2
2
Expiration Date Error
2
2
Failure to Disconnect
2
2
Unclear Information
2
2
Noise, Audible
2
2
Sharp Edges
1
1
Excessive Heating
1
1
Difficult or Delayed Separation
1
1
Unexpected Color
1
1
Thickening of Material
1
1
Obstruction of Flow
1
1
Patient-Device Incompatibility
1
1
Component or Accessory Incompatibility
1
1
Connection Problem
1
1
Device Dislodged or Dislocated
1
1
Device Damaged by Another Device
1
1
Mechanics Altered
1
1
Positioning Problem
1
1
Positioning Failure
1
1
Complete Blockage
1
1
Optical Decentration
1
1
Material Frayed
1
1
Device, or device fragments remain in patient
1
1
Peeled/Delaminated
1
1
Device Difficult to Setup or Prepare
1
1
Inadequacy of Device Shape and/or Size
1
1
Unraveled Material
1
1
Defective Component
1
1
Incomplete or Missing Packaging
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4276
4276
No Consequences Or Impact To Patient
1443
1443
Foreign Body In Patient
823
823
Insufficient Information
424
424
No Code Available
279
279
Device Embedded In Tissue or Plaque
175
175
No Known Impact Or Consequence To Patient
164
164
Not Applicable
114
114
No Patient Involvement
92
92
Injury
57
57
No Information
40
40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
18
18
Bone Fracture(s)
15
15
Unspecified Tissue Injury
13
13
Failure of Implant
12
12
Burn(s)
8
8
Hemorrhage/Bleeding
7
7
Patient Problem/Medical Problem
6
6
Unspecified Infection
6
6
Pain
6
6
Blood Loss
3
3
Perforation
3
3
Tissue Damage
3
3
Impaired Healing
3
3
Perforation of Vessels
2
2
Nerve Damage
2
2
Paralysis
2
2
Discomfort
2
2
Hypersensitivity/Allergic reaction
2
2
Hematoma
1
1
Thromboembolism
1
1
Necrosis
1
1
Swelling/ Edema
1
1
Bacterial Infection
1
1
Pneumothorax
1
1
Fever
1
1
Rupture
1
1
Vessel Or Plaque, Device Embedded In
1
1
Vascular Dissection
1
1
Spinal Column Injury
1
1
Sepsis
1
1
Superficial (First Degree) Burn
1
1
Deformity/ Disfigurement
1
1
Full thickness (Third Degree) Burn
1
1
Unspecified Musculoskeletal problem
1
1
Limb Fracture
1
1
Ischemia Stroke
1
1
Laceration(s)
1
1
Foreign Body Reaction
1
1
Death
1
1
Chills
1
1
Swelling
1
1
Loss of Range of Motion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
AAP Implantate Ag
III
Dec-22-2019
2
Arthrex, Inc.
II
Mar-26-2021
3
Biomet, Inc.
II
Dec-17-2020
4
Flower Orthopedics Corporation
II
Oct-14-2021
5
NEOSTEO
II
Aug-09-2021
6
Paragon 28, Inc.
II
Sep-17-2021
7
Trilliant Surgical, LLC
II
May-05-2020
8
Waldemar Link GmbH & Co. KG (Mfg Site)
II
Mar-06-2024
9
Zimmer GmbH
II
May-23-2019
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