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TPLC
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show TPLC since
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2024
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Device
template
Product Code
HWT
Regulation Number
888.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
78
78
2015
93
93
2016
444
444
2017
651
651
2018
713
713
2019
741
741
2020
938
938
2021
2177
2177
2022
2096
2096
2023
2601
2601
2024
876
876
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
5474
5474
Naturally Worn
1463
1463
Device-Device Incompatibility
1238
1238
Scratched Material
958
958
Crack
870
870
Detachment of Device or Device Component
618
618
Fracture
487
487
Material Deformation
456
456
Material Twisted/Bent
410
410
Contamination /Decontamination Problem
301
301
Illegible Information
293
293
Material Integrity Problem
195
195
Mechanical Jam
155
155
Component Missing
155
155
Peeled/Delaminated
148
148
Appropriate Term/Code Not Available
146
146
Material Discolored
144
144
Adverse Event Without Identified Device or Use Problem
111
111
Insufficient Information
89
89
No Apparent Adverse Event
70
70
Unintended Movement
64
64
Entrapment of Device
64
64
Use of Device Problem
55
55
Incorrect Measurement
50
50
Corroded
48
48
Failure to Cut
40
40
Physical Resistance/Sticking
40
40
Material Fragmentation
35
35
Disassembly
34
34
Loose or Intermittent Connection
32
32
Difficult to Remove
27
27
Device Operates Differently Than Expected
26
26
Device Dislodged or Dislocated
26
26
Structural Problem
23
23
Mechanical Problem
23
23
Bent
23
23
Device Contamination With Biological Material
22
22
Dull, Blunt
21
21
Connection Problem
18
18
Fitting Problem
17
17
Difficult to Insert
14
14
Compatibility Problem
12
12
Off-Label Use
10
10
Residue After Decontamination
10
10
Device Slipped
10
10
Improper or Incorrect Procedure or Method
10
10
Separation Failure
9
9
Difficult to Open or Close
9
9
Inadequacy of Device Shape and/or Size
8
8
Detachment Of Device Component
8
8
Loss of or Failure to Bond
7
7
Loss of Osseointegration
7
7
Device Markings/Labelling Problem
7
7
Malposition of Device
6
6
Device Operational Issue
6
6
Positioning Problem
6
6
Separation Problem
6
6
Difficult or Delayed Separation
6
6
Migration
5
5
Defective Device
5
5
Device Issue
4
4
Device Reprocessing Problem
4
4
Component Falling
4
4
Failure To Adhere Or Bond
4
4
Manufacturing, Packaging or Shipping Problem
4
4
Material Distortion
3
3
Difficult to Advance
3
3
Loosening of Implant Not Related to Bone-Ingrowth
3
3
Material Split, Cut or Torn
3
3
Degraded
3
3
Migration or Expulsion of Device
3
3
Device Damaged Prior to Use
3
3
Sticking
3
3
Unstable
3
3
Device Or Device Fragments Location Unknown
3
3
Patient-Device Incompatibility
2
2
Deformation Due to Compressive Stress
2
2
Delivered as Unsterile Product
2
2
Defective Component
2
2
Tear, Rip or Hole in Device Packaging
2
2
Pitted
2
2
Material Disintegration
2
2
Incomplete or Inadequate Connection
2
2
Patient Device Interaction Problem
2
2
Device Handling Problem
2
2
Torn Material
2
2
Device Damaged by Another Device
2
2
Device Contaminated During Manufacture or Shipping
2
2
Lack of Maintenance Documentation or Guidelines
1
1
Difficult to Open or Remove Packaging Material
1
1
Mechanics Altered
1
1
Protective Measures Problem
1
1
Packaging Problem
1
1
Physical Property Issue
1
1
Noise, Audible
1
1
Misassembly by Users
1
1
Device Difficult to Maintain
1
1
Inaccurate Information
1
1
Display Difficult to Read
1
1
Device Expiration Issue
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
7406
7406
No Consequences Or Impact To Patient
1901
1901
No Information
623
623
No Known Impact Or Consequence To Patient
545
545
Insufficient Information
447
447
No Code Available
182
182
No Patient Involvement
168
168
Not Applicable
86
86
Pain
55
55
Foreign Body In Patient
45
45
Reaction
35
35
Unspecified Infection
29
29
Device Embedded In Tissue or Plaque
28
28
Bone Fracture(s)
24
24
Sedation
21
21
Injury
9
9
Joint Dislocation
8
8
Limb Fracture
8
8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
8
8
Loss of Range of Motion
6
6
Tissue Damage
4
4
Osteolysis
4
4
Impaired Healing
4
4
Joint Laxity
4
4
Metal Related Pathology
3
3
Unspecified Tissue Injury
3
3
Physical Asymmetry
3
3
Ambulation Difficulties
3
3
Paresis
3
3
Discomfort
3
3
Complaint, Ill-Defined
3
3
Cyst(s)
3
3
Failure of Implant
3
3
Muscle Weakness
3
3
Inflammation
2
2
Laceration(s)
2
2
Bruise/Contusion
2
2
Wound Dehiscence
2
2
Neck Pain
2
2
Swelling/ Edema
2
2
Unspecified Musculoskeletal problem
1
1
Blood Loss
1
1
Inadequate Osseointegration
1
1
Limited Mobility Of The Implanted Joint
1
1
Patient Problem/Medical Problem
1
1
Joint Swelling
1
1
Depression
1
1
Non-union Bone Fracture
1
1
Swelling
1
1
Synovitis
1
1
Paralysis
1
1
Pulmonary Embolism
1
1
Adhesion(s)
1
1
Hematoma
1
1
Death
1
1
Fall
1
1
Fever
1
1
Foreign Body Reaction
1
1
Infiltration into Tissue
1
1
Nerve Damage
1
1
Occlusion
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Feb-12-2018
2
Aesculap Implant Systems LLC
II
Jul-31-2012
3
Biomet Microfixation, LLC
II
May-12-2017
4
Biomet, Inc.
II
Jul-14-2015
5
Biomet, Inc.
II
Oct-16-2014
6
DePuy Orthopaedics, Inc.
II
Jul-20-2022
7
DePuy Orthopaedics, Inc.
II
Apr-09-2014
8
DePuy Orthopaedics, Inc.
II
Jun-07-2013
9
Encore Medical, Lp
II
Jul-27-2015
10
Integra LifeSciences Corp.
II
Apr-20-2018
11
Materialise USA LLC
II
Aug-24-2022
12
Waldemar Link GmbH & Co. KG (Corp. Hq.)
II
Aug-26-2013
13
Zimmer Inc.
II
Dec-14-2010
14
Zimmer Inc.
II
Jan-23-2009
15
Zimmer, Inc.
II
Dec-06-2013
16
Zimmer, Inc.
II
Nov-19-2012
17
Zimmer, Inc.
II
Sep-28-2012
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