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TPLC
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show TPLC since
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Device
template
Regulation Description
Template for clinical use.
Product Code
HWT
Regulation Number
888.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
938
938
2021
2177
2177
2022
2096
2096
2023
2601
2601
2024
2419
2419
2025
177
177
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
4924
4924
Naturally Worn
1638
1638
Device-Device Incompatibility
1335
1335
Scratched Material
1116
1116
Crack
781
781
Detachment of Device or Device Component
718
718
Material Deformation
525
525
Illegible Information
388
388
Material Twisted/Bent
337
337
Contamination /Decontamination Problem
323
323
Fracture
265
265
Material Integrity Problem
207
207
No Apparent Adverse Event
176
176
Mechanical Jam
145
145
Material Discolored
144
144
Peeled/Delaminated
135
135
Adverse Event Without Identified Device or Use Problem
88
88
Entrapment of Device
72
72
Unintended Movement
70
70
Corroded
61
61
Use of Device Problem
52
52
Component Missing
45
45
Incorrect Measurement
44
44
Failure to Cut
43
43
Structural Problem
22
22
Physical Resistance/Sticking
16
16
Improper or Incorrect Procedure or Method
15
15
Mechanical Problem
14
14
Device Dislodged or Dislocated
14
14
Material Fragmentation
12
12
Insufficient Information
12
12
Compatibility Problem
11
11
Appropriate Term/Code Not Available
11
11
Off-Label Use
11
11
Dull, Blunt
9
9
Loss of Osseointegration
8
8
Difficult to Open or Close
8
8
Loose or Intermittent Connection
7
7
Loss of or Failure to Bond
7
7
Difficult or Delayed Separation
5
5
Migration
4
4
Residue After Decontamination
4
4
Device Slipped
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Difficult to Remove
3
3
Material Split, Cut or Torn
3
3
Device Damaged Prior to Use
3
3
Inadequacy of Device Shape and/or Size
2
2
Activation, Positioning or Separation Problem
2
2
Patient-Device Incompatibility
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
8602
8602
Insufficient Information
986
986
No Consequences Or Impact To Patient
660
660
No Code Available
121
121
No Patient Involvement
66
66
No Known Impact Or Consequence To Patient
42
42
Foreign Body In Patient
35
35
Pain
21
21
Bone Fracture(s)
17
17
Not Applicable
16
16
Unspecified Infection
13
13
No Information
11
11
Limb Fracture
9
9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Physical Asymmetry
6
6
Joint Dislocation
5
5
Injury
4
4
Loss of Range of Motion
4
4
Joint Laxity
4
4
Cyst(s)
3
3
Metal Related Pathology
3
3
Unspecified Tissue Injury
3
3
Laceration(s)
2
2
Swelling/ Edema
2
2
Failure of Implant
2
2
Bruise/Contusion
2
2
Osteolysis
2
2
Unspecified Musculoskeletal problem
1
1
Inflammation
1
1
Foreign Body Reaction
1
1
Adhesion(s)
1
1
Device Embedded In Tissue or Plaque
1
1
Pulmonary Embolism
1
1
Ambulation Difficulties
1
1
Spinal Cord Injury
1
1
Unspecified Nervous System Problem
1
1
Nerve Damage
1
1
Non-union Bone Fracture
1
1
Depression
1
1
Synovitis
1
1
Discomfort
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
DePuy Orthopaedics, Inc.
II
Jul-20-2022
2
LINK BIO CORP
II
Jul-25-2024
3
Materialise USA LLC
II
Aug-24-2022
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