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TPLC
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Device
appliance, fixation, nail/blade/plate combination, multiple component
Product Code
KTT
Regulation Number
888.3030
Device Class
2
Premarket Reviews
Manufacturer
Decision
AIKE (SHANGHAI) MEDICAL INSTRUMENT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
ARROWHEAD DE, LLC
SUBSTANTIALLY EQUIVALENT
2
AUSTIN MILLER TRAUMA LLC
SUBSTANTIALLY EQUIVALENT
1
DEPUY SYNTHES
SUBSTANTIALLY EQUIVALENT
1
GLOBUS MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
GLW MEDICAL INNOVATION
SUBSTANTIALLY EQUIVALENT
1
LIFE SPINE INC.
SUBSTANTIALLY EQUIVALENT
1
NEW STANDARD DEVICE DBA METALOGIX
SUBSTANTIALLY EQUIVALENT
1
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
ORTHOFIX SRL
SUBSTANTIALLY EQUIVALENT
1
ORTHONOVIS, INC.
SUBSTANTIALLY EQUIVALENT
1
ORTHOPAEDIC IMPLANT COMPANY
SUBSTANTIALLY EQUIVALENT
2
ORTHOPEDIATRICS CORP.
SUBSTANTIALLY EQUIVALENT
2
ORTHOSPIN
SUBSTANTIALLY EQUIVALENT
1
ORTHOSPIN LTD
SUBSTANTIALLY EQUIVALENT
1
PARAGON 28, INC
SUBSTANTIALLY EQUIVALENT
1
S H PITKAR ORTHOTOOLS PVT LTD
SUBSTANTIALLY EQUIVALENT
1
S H PITKAR ORTHOTOOLS PVT LTD.
SUBSTANTIALLY EQUIVALENT
2
SEQUEL MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
2
STRYKER GMBH
SUBSTANTIALLY EQUIVALENT
2
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC
SUBSTANTIALLY EQUIVALENT
1
SYNTHES (USA) PRODUCTS, LLC
SUBSTANTIALLY EQUIVALENT
2
VILEX LLC
SUBSTANTIALLY EQUIVALENT
1
VILEX, LLC
SUBSTANTIALLY EQUIVALENT
2
WISHBONE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
WRIGHT MEDICAL TECHNOLOGY, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
597
597
2019
800
800
2020
942
942
2021
963
963
2022
642
643
2023
187
187
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1734
1734
Break
727
727
Device-Device Incompatibility
363
363
Migration
348
349
Fracture
111
111
Mechanical Problem
89
89
Material Twisted/Bent
81
81
Insufficient Information
77
77
Material Deformation
62
62
Unintended Movement
62
62
Device Slipped
61
61
Migration or Expulsion of Device
52
52
No Apparent Adverse Event
49
49
Mechanical Jam
46
46
Appropriate Term/Code Not Available
44
44
Use of Device Problem
34
34
Device Operates Differently Than Expected
30
30
Crack
23
23
Manufacturing, Packaging or Shipping Problem
23
23
Loosening of Implant Not Related to Bone-Ingrowth
22
22
Detachment of Device or Device Component
21
21
Defective Device
19
19
Corroded
19
19
Loss of Osseointegration
16
16
Contamination /Decontamination Problem
15
15
Entrapment of Device
15
15
Physical Resistance/Sticking
14
14
Patient Device Interaction Problem
13
13
Mechanics Altered
11
11
Material Integrity Problem
10
10
Loose or Intermittent Connection
10
10
Difficult to Remove
9
9
Improper or Incorrect Procedure or Method
8
8
Connection Problem
8
8
Difficult to Advance
8
8
Failure to Osseointegrate
7
7
Material Fragmentation
7
7
Naturally Worn
7
7
Device Dislodged or Dislocated
7
7
Device Inoperable
6
6
Patient-Device Incompatibility
6
6
Failure to Cut
5
5
Failure to Align
5
5
Material Separation
5
5
Difficult to Insert
5
5
Material Discolored
5
5
Degraded
4
4
Difficult or Delayed Positioning
4
4
Positioning Failure
4
4
Detachment Of Device Component
4
4
Component Falling
4
4
Device Difficult to Setup or Prepare
4
4
Fitting Problem
4
4
Device Contaminated During Manufacture or Shipping
4
4
Device Difficult to Maintain
4
4
Incomplete or Inadequate Connection
4
4
Positioning Problem
3
3
Device Damaged Prior to Use
3
3
Unstable
3
3
Microbial Contamination of Device
3
3
Component Missing
3
3
Device Damaged by Another Device
3
3
Device Markings/Labelling Problem
3
3
Malposition of Device
3
3
Unintended System Motion
3
3
Disconnection
3
3
Failure To Adhere Or Bond
3
3
Bent
3
3
Material Frayed
2
2
Application Program Problem
2
2
Device Operational Issue
2
2
Defective Component
2
2
Unclear Information
2
2
Material Split, Cut or Torn
1
1
Failure to Eject
1
1
Activation Problem
1
1
Difficult or Delayed Separation
1
1
Premature Separation
1
1
Device Handling Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Material Protrusion/Extrusion
1
1
Packaging Problem
1
1
Compatibility Problem
1
1
Solder Joint Fracture
1
1
Dull, Blunt
1
1
Expiration Date Error
1
1
Separation Failure
1
1
Difficult to Open or Close
1
1
Deformation Due to Compressive Stress
1
1
Calibration Problem
1
1
Chemical Problem
1
1
Folded
1
1
Activation, Positioning or Separation Problem
1
1
Inflation Problem
1
1
Loss of or Failure to Bond
1
1
Use of Incorrect Control/Treatment Settings
1
1
Overheating of Device
1
1
Unsealed Device Packaging
1
1
Nonstandard Device
1
1
Unintended Ejection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
968
968
No Clinical Signs, Symptoms or Conditions
615
615
Pain
424
424
Non-union Bone Fracture
396
396
Failure of Implant
359
359
Bone Fracture(s)
345
345
Unspecified Infection
274
274
No Consequences Or Impact To Patient
221
221
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
215
215
No Known Impact Or Consequence To Patient
165
165
Necrosis
155
155
Injury
151
151
Post Operative Wound Infection
139
139
No Patient Involvement
112
112
Impaired Healing
89
89
Insufficient Information
85
86
Physical Asymmetry
74
74
Loss of Range of Motion
49
49
Discomfort
43
43
Malunion of Bone
41
41
Unspecified Tissue Injury
33
33
Foreign Body In Patient
32
32
Hypersensitivity/Allergic reaction
27
27
Joint Dislocation
25
25
No Information
24
24
Nerve Damage
23
23
Deformity/ Disfigurement
22
22
Not Applicable
18
18
Wound Dehiscence
16
16
Swelling/ Edema
15
15
Blood Loss
14
14
Hematoma
14
14
Reaction
13
13
Device Embedded In Tissue or Plaque
13
13
Limb Fracture
12
12
Sepsis
12
12
Fluid Discharge
11
11
Arthritis
10
10
Fall
10
10
Bacterial Infection
9
9
Skin Erosion
9
9
Paralysis
8
8
Inflammation
8
8
Patient Problem/Medical Problem
8
8
Metal Related Pathology
8
8
Thrombosis/Thrombus
8
8
Death
7
7
Ambulation Difficulties
7
7
Swelling
6
6
Fistula
6
6
Hemorrhage/Bleeding
6
6
Implant Pain
6
6
Skin Inflammation/ Irritation
5
5
Pulmonary Embolism
5
5
Thrombosis
5
5
Tissue Damage
4
4
Cellulitis
4
4
Perforation
4
4
Cyst(s)
4
4
Purulent Discharge
3
3
Weakness
3
3
Hypoesthesia
3
3
Limited Mobility Of The Implanted Joint
3
3
Numbness
3
3
Osteolysis
3
3
Spinal Cord Injury
3
3
Inadequate Osseointegration
2
2
Ulcer
2
2
Burning Sensation
2
2
Tingling
2
2
Stroke/CVA
2
2
Abscess
2
2
Erosion
2
2
Fever
2
2
Foreign Body Sensation in Eye
2
2
Irritation
2
2
Muscular Rigidity
1
1
Myocardial Infarction
1
1
Seroma
1
1
Internal Organ Perforation
1
1
Calcium Deposits/Calcification
1
1
Anemia
1
1
Ossification
1
1
Congenital Defect/Deformity
1
1
Fatigue
1
1
Embolism
1
1
Erythema
1
1
Skin Irritation
1
1
Discharge
1
1
Hip Fracture
1
1
Disability
1
1
Thromboembolism
1
1
Tissue Breakdown
1
1
Needle Stick/Puncture
1
1
Bronchopneumonia
1
1
Respiratory Tract Infection
1
1
Drug Resistant Bacterial Infection
1
1
Subluxation
1
1
Joint Contracture
1
1
Decreased Appetite
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Howmedica Osteonics Corp.
II
Feb-16-2022
2
Medicalplastic S.R.L.
II
Nov-17-2021
3
New Standard Device Inc
II
Aug-29-2022
4
New Standard Device Inc
II
Jun-03-2022
5
OrthoPediatrics Corp
II
Sep-06-2022
6
Orthofix Srl
II
Nov-14-2019
7
Orthofix Srl
II
Jun-05-2018
8
Stryker GmbH
II
Mar-01-2023
9
Stryker GmbH
II
Oct-29-2018
10
Stryker GmbH
II
Sep-22-2018
11
Stryker GmbH
II
Apr-26-2018
12
Wishbone Medical, Inc.
II
Feb-07-2023
13
Zimmer Biomet, Inc.
II
Nov-22-2019
14
Zimmer Biomet, Inc.
II
Nov-07-2019
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