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TPLC
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show TPLC since
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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
ARTHREX INC
SUBSTANTIALLY EQUIVALENT
1
AUSTIN MILLER TRAUMA LLC
SUBSTANTIALLY EQUIVALENT
1
AUXEIN MEDICAL PRIVATE LIMITED
SUBSTANTIALLY EQUIVALENT
1
DEPUY SYNTHES
SUBSTANTIALLY EQUIVALENT
1
GLW MEDICAL INNOVATION
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
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
3
SYNTHES (USA) PRODUCTS, LLC
SUBSTANTIALLY EQUIVALENT
1
VILEX LLC
SUBSTANTIALLY EQUIVALENT
1
VILEX, LLC
SUBSTANTIALLY EQUIVALENT
2
WISHBONE MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
3
MDR Year
MDR Reports
MDR Events
2019
800
800
2020
942
942
2021
961
961
2022
627
628
2023
553
553
2024
110
110
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
1704
1704
Break
707
707
Migration
424
425
Device-Device Incompatibility
389
389
Fracture
143
143
Material Twisted/Bent
86
86
Mechanical Problem
62
62
Material Deformation
56
56
Device Slipped
53
53
Insufficient Information
53
53
No Apparent Adverse Event
50
50
Migration or Expulsion of Device
48
48
Mechanical Jam
42
42
Appropriate Term/Code Not Available
41
41
Use of Device Problem
37
37
Manufacturing, Packaging or Shipping Problem
24
24
Loosening of Implant Not Related to Bone-Ingrowth
22
22
Defective Device
22
22
Crack
22
22
Entrapment of Device
20
20
Corroded
19
19
Detachment of Device or Device Component
19
19
Loss of Osseointegration
16
16
Physical Resistance/Sticking
14
14
Difficult to Advance
12
12
Material Integrity Problem
12
12
Unintended Movement
11
11
Mechanics Altered
10
10
Improper or Incorrect Procedure or Method
10
10
Device Contaminated During Manufacture or Shipping
9
9
Connection Problem
8
8
Naturally Worn
7
7
Unintended System Motion
7
7
Device Dislodged or Dislocated
6
6
Failure to Osseointegrate
6
6
Failure to Cut
5
5
Loose or Intermittent Connection
5
5
Device Difficult to Setup or Prepare
5
5
Off-Label Use
5
5
Material Discolored
5
5
Material Fragmentation
5
5
Degraded
4
4
Difficult or Delayed Positioning
4
4
Positioning Failure
4
4
Difficult to Remove
4
4
Material Separation
4
4
Device Damaged Prior to Use
4
4
Patient-Device Incompatibility
4
4
Incomplete or Inadequate Connection
4
4
Patient Device Interaction Problem
4
4
Positioning Problem
3
3
Failure to Align
3
3
Component Missing
3
3
Device Markings/Labelling Problem
3
3
Device Damaged by Another Device
3
3
Unstable
3
3
Difficult to Insert
3
3
Disconnection
3
3
Material Frayed
2
2
Contamination /Decontamination Problem
2
2
Fitting Problem
2
2
Malposition of Device
2
2
Device Difficult to Maintain
2
2
Unclear Information
2
2
Material Split, Cut or Torn
1
1
Failure to Eject
1
1
Therapeutic or Diagnostic Output Failure
1
1
Packaging Problem
1
1
Device Handling Problem
1
1
Activation Problem
1
1
Difficult or Delayed Separation
1
1
Premature Separation
1
1
Expiration Date Error
1
1
Application Program Problem
1
1
Deformation Due to Compressive Stress
1
1
Calibration Problem
1
1
Chemical Problem
1
1
Solder Joint Fracture
1
1
Dull, Blunt
1
1
Defective Component
1
1
Activation, Positioning or Separation Problem
1
1
Difficult to Open or Close
1
1
Material Protrusion/Extrusion
1
1
Inflation Problem
1
1
Unintended Ejection
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
Misassembled
1
1
Nonstandard Device
1
1
Inadequacy of Device Shape and/or Size
1
1
Material Too Rigid or Stiff
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Code Available
771
771
No Clinical Signs, Symptoms or Conditions
732
732
Non-union Bone Fracture
418
418
Pain
402
402
Failure of Implant
349
349
Bone Fracture(s)
338
338
Unspecified Infection
241
241
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
213
213
Necrosis
211
211
Insufficient Information
177
178
No Consequences Or Impact To Patient
164
164
Injury
146
146
Post Operative Wound Infection
143
143
Physical Asymmetry
107
107
No Patient Involvement
85
85
No Known Impact Or Consequence To Patient
80
80
Impaired Healing
60
60
Loss of Range of Motion
48
48
Malunion of Bone
43
43
Unspecified Tissue Injury
41
41
Fall
40
40
Discomfort
37
37
Foreign Body In Patient
30
30
Deformity/ Disfigurement
29
29
Hypersensitivity/Allergic reaction
27
27
Limb Fracture
26
26
Joint Dislocation
25
25
Nerve Damage
23
23
Swelling/ Edema
21
21
Hematoma
20
20
Wound Dehiscence
16
16
Arthritis
13
13
Reaction
11
11
Sepsis
11
11
Fluid Discharge
11
11
No Information
11
11
Thrombosis/Thrombus
10
10
Blood Loss
10
10
Skin Erosion
9
9
Inflammation
9
9
Foreign Body Embolism
9
9
Metal Related Pathology
8
8
Device Embedded In Tissue or Plaque
8
8
Bacterial Infection
8
8
Ambulation Difficulties
8
8
Death
7
7
Fistula
7
7
Hemorrhage/Bleeding
7
7
Implant Pain
7
7
Skin Inflammation/ Irritation
6
6
Patient Problem/Medical Problem
6
6
Not Applicable
5
5
Perforation
5
5
Pulmonary Embolism
5
5
Thrombosis
5
5
Cellulitis
4
4
Cyst(s)
4
4
Purulent Discharge
3
3
Weakness
3
3
Hypoesthesia
3
3
Ulcer
3
3
Spinal Cord Injury
3
3
Numbness
3
3
Osteolysis
3
3
Irritability
2
2
Swelling
2
2
Burning Sensation
2
2
Tingling
2
2
Tissue Damage
2
2
Stroke/CVA
2
2
Abscess
2
2
Anemia
2
2
Erosion
2
2
Fever
2
2
Foreign Body Sensation in Eye
2
2
Paralysis
2
2
Inadequate Osseointegration
2
2
Limited Mobility Of The Implanted Joint
2
2
Tissue Breakdown
1
1
Thromboembolism
1
1
Heart Failure/Congestive Heart Failure
1
1
Unspecified Heart Problem
1
1
Subluxation
1
1
Joint Contracture
1
1
Neuralgia
1
1
Embolism/Embolus
1
1
Drug Resistant Bacterial Infection
1
1
Decreased Appetite
1
1
Unequal Limb Length
1
1
Unspecified Musculoskeletal problem
1
1
Internal Organ Perforation
1
1
Ischemia
1
1
Muscular Rigidity
1
1
Myocardial Infarction
1
1
Calcium Deposits/Calcification
1
1
Ossification
1
1
Congenital Defect/Deformity
1
1
Fatigue
1
1
Embolism
1
1
Erythema
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
Jun-09-2023
4
New Standard Device Inc
II
Aug-29-2022
5
New Standard Device Inc
II
Jun-03-2022
6
OrthoPediatrics Corp
II
Sep-06-2022
7
Orthofix Srl
II
Nov-14-2019
8
Stryker GmbH
II
Mar-01-2023
9
Wishbone Medical, Inc.
II
Feb-07-2023
10
Zimmer Biomet, Inc.
II
Nov-22-2019
11
Zimmer Biomet, Inc.
II
Nov-07-2019
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