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TPLC
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Device
staple, fixation, bone
Product Code
JDR
Regulation Number
888.3030
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARTHREX INC.
SUBSTANTIALLY EQUIVALENT
1
CROSSROADS EXTEMITY SYSTEMS, LLC
SUBSTANTIALLY EQUIVALENT
1
GRAMERCY EXTREMITY ORTHOPEDICS, LLC
SUBSTANTIALLY EQUIVALENT
1
MEDACTA INTERNATIONAL SA
SUBSTANTIALLY EQUIVALENT
1
MEDARTIS AG
SUBSTANTIALLY EQUIVALENT
1
MEDARTIS INC.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDLINE INDUSTRIES, LP
SUBSTANTIALLY EQUIVALENT
2
MEDSHAPE, INC.
SUBSTANTIALLY EQUIVALENT
2
NEOSTEO
SUBSTANTIALLY EQUIVALENT
1
NEXTREMITY SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
NOVASTEP
SUBSTANTIALLY EQUIVALENT
1
NVISION BIOMEDICAL TECHNOLOGIES, LLC
SUBSTANTIALLY EQUIVALENT
1
ORTHO SOLUTIONS UK LTD.
SUBSTANTIALLY EQUIVALENT
1
PARAGON 28 INC
SUBSTANTIALLY EQUIVALENT
1
PARAGON 28, INC.
SUBSTANTIALLY EQUIVALENT
1
RESTOR3D
SUBSTANTIALLY EQUIVALENT
1
RMR ORTHO, LLC
SUBSTANTIALLY EQUIVALENT
1
STRYKER GMBH
SUBSTANTIALLY EQUIVALENT
1
SYNTHES (USA) PRODUCTS, LLC
SUBSTANTIALLY EQUIVALENT
1
TREACE MEDICAL CONCEPTS
SUBSTANTIALLY EQUIVALENT
2
TRIMED, INC.
SUBSTANTIALLY EQUIVALENT
1
TYBER MEDICAL, LLC.
SUBSTANTIALLY EQUIVALENT
1
VILEX, LLC
SUBSTANTIALLY EQUIVALENT
1
WRIGHT MEDICAL
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
242
242
2020
234
234
2021
210
210
2022
202
209
2023
175
175
2024
93
93
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
344
344
Adverse Event Without Identified Device or Use Problem
252
256
Detachment of Device or Device Component
123
123
Fracture
78
78
Migration
32
35
Device Dislodged or Dislocated
31
31
Manufacturing, Packaging or Shipping Problem
29
29
Device-Device Incompatibility
29
29
Physical Resistance/Sticking
22
22
Difficult to Advance
21
21
Material Split, Cut or Torn
19
19
Material Separation
17
17
Appropriate Term/Code Not Available
17
17
Migration or Expulsion of Device
16
16
Crack
16
16
Loosening of Implant Not Related to Bone-Ingrowth
15
15
Insufficient Information
13
13
Entrapment of Device
9
9
Material Frayed
9
9
Material Deformation
8
8
Patient Device Interaction Problem
8
8
No Apparent Adverse Event
6
6
Material Fragmentation
6
6
Failure to Advance
6
6
Difficult to Remove
5
5
Unintended Movement
5
5
Material Twisted/Bent
5
5
Mechanical Jam
4
4
Patient-Device Incompatibility
4
4
Loose or Intermittent Connection
4
4
Mechanical Problem
4
4
Activation Problem
4
4
Inaccurate Information
4
4
Corroded
3
3
Delivered as Unsterile Product
3
3
Defective Component
3
3
Device Damaged by Another Device
3
3
Packaging Problem
3
3
Device Contaminated During Manufacture or Shipping
3
3
Therapeutic or Diagnostic Output Failure
2
2
Failure to Eject
2
2
Firing Problem
2
2
Failure to Align
2
2
Material Integrity Problem
2
2
Failure to Form Staple
2
2
Failure to Cut
2
2
Connection Problem
2
2
Activation, Positioning or Separation Problem
2
2
Component Missing
2
2
Fitting Problem
2
2
Flaked
2
2
Inadequacy of Device Shape and/or Size
2
2
Difficult or Delayed Positioning
2
2
Positioning Failure
2
2
Material Disintegration
1
1
Unintended Ejection
1
1
Degraded
1
1
Melted
1
1
Nonstandard Device
1
1
Difficult to Insert
1
1
Device Slipped
1
1
Stretched
1
1
Unstable
1
1
Use of Device Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Output above Specifications
1
1
Off-Label Use
1
1
Device Damaged Prior to Use
1
1
Expiration Date Error
1
1
Separation Failure
1
1
Tear, Rip or Hole in Device Packaging
1
1
Loss of Osseointegration
1
1
Device Markings/Labelling Problem
1
1
Defective Device
1
1
Contamination /Decontamination Problem
1
1
Expulsion
1
1
Device Difficult to Maintain
1
1
Positioning Problem
1
1
Output Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
449
449
No Consequences Or Impact To Patient
104
104
Pain
80
80
No Code Available
59
59
Non-union Bone Fracture
58
58
Insufficient Information
56
56
Injury
55
55
Tissue Damage
48
48
Failure of Implant
46
46
Not Applicable
45
45
No Known Impact Or Consequence To Patient
41
41
Foreign Body In Patient
34
34
Unspecified Infection
28
28
Unspecified Tissue Injury
23
23
Loss of Range of Motion
21
24
Bone Fracture(s)
20
20
No Patient Involvement
19
19
Post Operative Wound Infection
19
19
Perforation
15
15
Impaired Healing
14
14
No Information
13
13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Implant Pain
11
15
Discomfort
11
11
Wound Dehiscence
8
8
Hypersensitivity/Allergic reaction
6
6
Foreign Body Reaction
5
5
Device Embedded In Tissue or Plaque
5
5
Malunion of Bone
4
4
Joint Dislocation
4
4
Hematoma
4
4
Cyst(s)
4
4
Fall
4
4
Abscess
4
4
Inflammation
4
4
Rupture
4
4
Arthritis
3
3
Cellulitis
3
3
Osteolysis
3
3
Synovitis
3
3
Skin Infection
3
3
Swelling/ Edema
3
3
Skin Inflammation/ Irritation
2
2
Numbness
2
2
Unspecified Musculoskeletal problem
2
2
Physical Asymmetry
2
2
Stroke/CVA
2
2
Bacterial Infection
2
2
Erosion
2
2
Fever
2
2
Ulcer
2
2
Nerve Damage
2
2
Swelling
2
2
Muscular Rigidity
2
2
Necrosis
1
1
Laceration(s)
1
1
Damage to Ligament(s)
1
1
Lupus
1
1
Seroma
1
1
Skin Discoloration
1
1
Weakness
1
1
Erythema
1
1
Hyperplasia
1
1
Ossification
1
1
Muscle/Tendon Damage
1
1
Osteomyelitis
1
1
Joint Contracture
1
1
Hypoesthesia
1
1
Deformity/ Disfigurement
1
1
Joint Disorder
1
1
Reaction
1
1
Organ Dehiscence
1
1
Ambulation Difficulties
1
1
Inadequate Osseointegration
1
1
Patient Problem/Medical Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Mar-18-2022
2
Merete Medical GmbH
II
Feb-17-2022
3
Stryker GmbH
II
Nov-16-2020
4
Synthes (USA) Products LLC
II
Oct-18-2022
5
Synthes (USA) Products LLC
II
Oct-06-2022
6
Wright Medical Technology, Inc.
II
Mar-31-2022
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