Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
Back to Search Results
Device
fastener, fixation, biodegradable, soft tissue
Product Code
MAI
Regulation Number
888.3030
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACUITIVE TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
1
ACUITIVE TECHNOLOGIES, INC.
SUBSTANTIALLY EQUIVALENT
4
AJU PHARM CO., LTD.
SUBSTANTIALLY EQUIVALENT
4
ARTHREX INC.
SUBSTANTIALLY EQUIVALENT
16
ARTHREX, INC.
SUBSTANTIALLY EQUIVALENT
2
B-ONE ORTHO, CORP
SUBSTANTIALLY EQUIVALENT
1
CONMED CORPORATION
SUBSTANTIALLY EQUIVALENT
1
EMBODY, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDACTA INTERNATIONAL SA
SUBSTANTIALLY EQUIVALENT
1
MEDOS INTERNATIONAL SARL
SUBSTANTIALLY EQUIVALENT
5
NANOFIBER SOLUTIONS, LLC
SUBSTANTIALLY EQUIVALENT
3
OSSIO LTD.
SUBSTANTIALLY EQUIVALENT
1
OSTEONIC CO., LTD.
SUBSTANTIALLY EQUIVALENT
3
PARCUS MEDICAL
SUBSTANTIALLY EQUIVALENT
1
PARCUS MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
2
S.B.M. SAS SCIENCES FOR BIO MATERIALS
SUBSTANTIALLY EQUIVALENT
1
SCIENCE & BIO MATERIALS (S.B.M.) SAS
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
SMITH AND NEPHEW, INC
SUBSTANTIALLY EQUIVALENT
1
SMITH AND NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
SPORTWELDING GMBH
SUBSTANTIALLY EQUIVALENT
1
TEKNIMED
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2018
1590
1590
2019
1247
1247
2020
957
957
2021
1267
1267
2022
1432
1432
2023
1337
1337
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
4175
4175
Adverse Event Without Identified Device or Use Problem
867
867
Device-Device Incompatibility
419
419
Crack
246
246
Migration
218
218
Detachment of Device or Device Component
201
201
Fracture
187
187
Material Deformation
185
185
Migration or Expulsion of Device
161
161
Positioning Failure
124
124
Material Separation
120
120
Material Twisted/Bent
118
118
Device Dislodged or Dislocated
111
111
Material Split, Cut or Torn
87
87
Material Frayed
77
77
Difficult to Advance
74
74
Device Damaged Prior to Use
73
73
Mechanical Jam
67
67
Insufficient Information
62
62
Loose or Intermittent Connection
57
57
Entrapment of Device
56
56
Activation, Positioning or Separation Problem
53
53
Premature Activation
50
50
Failure to Advance
47
47
Material Fragmentation
43
43
Patient-Device Incompatibility
40
40
Deformation Due to Compressive Stress
39
39
Appropriate Term/Code Not Available
37
37
Patient Device Interaction Problem
35
35
Difficult to Insert
32
32
Difficult to Remove
27
27
Unintended Movement
27
27
Mechanical Problem
24
24
Positioning Problem
23
23
Loosening of Implant Not Related to Bone-Ingrowth
23
23
Defective Device
19
19
Physical Resistance/Sticking
18
18
Firing Problem
17
17
Delivered as Unsterile Product
17
17
Use of Device Problem
17
17
Packaging Problem
15
15
Manufacturing, Packaging or Shipping Problem
15
15
Device Contaminated During Manufacture or Shipping
13
13
Device Slipped
12
12
Detachment Of Device Component
12
12
Component Missing
11
11
Separation Failure
11
11
Failure to Fire
10
10
Loss of or Failure to Bond
10
10
Bent
9
9
Output Problem
9
9
Device Damaged by Another Device
7
7
Activation Problem
7
7
Unsealed Device Packaging
7
7
Material Rupture
7
7
Product Quality Problem
6
6
Unstable
6
6
Disconnection
6
6
Fitting Problem
6
6
Misfire
6
6
Expulsion
6
6
Material Integrity Problem
5
5
Device Fell
5
5
Peeled/Delaminated
5
5
Flaked
5
5
Improper or Incorrect Procedure or Method
4
4
Unexpected Therapeutic Results
4
4
Device Operates Differently Than Expected
4
4
Device Markings/Labelling Problem
4
4
Contamination /Decontamination Problem
3
3
No Apparent Adverse Event
3
3
Unraveled Material
3
3
Nonstandard Device
3
3
Expiration Date Error
3
3
Material Disintegration
3
3
Degraded
3
3
Difficult or Delayed Positioning
3
3
Failure To Adhere Or Bond
3
3
Component Incompatible
2
2
Material Invagination
2
2
Structural Problem
2
2
Device Contamination with Body Fluid
2
2
Failure to Osseointegrate
2
2
Defective Component
2
2
Device Appears to Trigger Rejection
2
2
Misassembled
2
2
Scratched Material
2
2
Therapeutic or Diagnostic Output Failure
2
2
Component Misassembled
2
2
Noise, Audible
2
2
Material Too Soft/Flexible
2
2
Program or Algorithm Execution Problem
2
2
Suction Failure
2
2
Separation Problem
2
2
Connection Problem
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Malposition of Device
2
2
Biocompatibility
2
2
Device Contamination with Chemical or Other Material
2
2
Installation-Related Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3049
3049
No Consequences Or Impact To Patient
2126
2126
No Known Impact Or Consequence To Patient
379
379
Not Applicable
368
368
Unspecified Tissue Injury
346
346
Foreign Body In Patient
308
308
Unspecified Infection
238
238
Insufficient Information
235
235
Injury
191
191
Tissue Damage
191
191
No Code Available
174
174
Pain
162
163
Failure of Implant
137
137
No Information
134
134
Device Embedded In Tissue or Plaque
103
103
Inflammation
44
44
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
42
42
Loss of Range of Motion
41
41
Rupture
41
41
Hypersensitivity/Allergic reaction
35
35
Nerve Damage
31
31
Foreign Body Reaction
29
29
Swelling
25
25
Swelling/ Edema
25
25
Reaction
21
21
Joint Laxity
18
18
Post Operative Wound Infection
16
16
No Patient Involvement
16
16
Impaired Healing
14
14
Rash
13
13
Perforation
13
13
Damage to Ligament(s)
12
12
Cyst(s)
12
12
Fluid Discharge
12
12
Joint Dislocation
11
11
Fever
11
11
Hemorrhage/Bleeding
11
11
Adhesion(s)
10
10
Bacterial Infection
10
10
Scar Tissue
10
10
Erythema
9
9
Hematoma
9
9
Abscess
8
8
Numbness
7
7
Muscle/Tendon Damage
7
7
Discomfort
6
6
Bone Fracture(s)
6
6
Purulent Discharge
5
5
Staphylococcus Aureus
5
5
Local Reaction
5
5
Synovitis
5
5
Nausea
4
4
Edema
4
4
Wound Dehiscence
4
4
Fatigue
4
4
Itching Sensation
4
4
Arthralgia
4
4
Dizziness
4
4
Thrombosis/Thrombus
4
4
Urticaria
3
3
Joint Disorder
3
3
Osteolysis
3
3
Respiratory Failure
3
3
Fibrosis
3
3
Tissue Breakdown
3
3
Headache
3
3
Autoimmune Disorder
3
3
Death
3
3
Thrombus
3
3
Skin Discoloration
3
3
Weakness
3
3
Burning Sensation
3
3
Renal Failure
2
2
Cellulitis
2
2
Laceration(s)
2
2
Muscle Spasm(s)
2
2
Patient Problem/Medical Problem
2
2
Weight Changes
2
2
Limited Mobility Of The Implanted Joint
2
2
Neck Stiffness
2
2
Anxiety
2
2
Ulcer
2
2
Osteomyelitis
2
2
Localized Skin Lesion
2
2
Reaction to Medicinal Component of Device
2
2
Skin Infection
2
2
Drug Resistant Bacterial Infection
1
1
Implant Pain
1
1
Skin Disorders
1
1
Subluxation
1
1
Ankylosis
1
1
Hypoesthesia
1
1
Skin Inflammation
1
1
Sweating
1
1
Osteopenia/ Osteoporosis
1
1
Skin Tears
1
1
Ambulation Difficulties
1
1
Alteration In Body Temperature
1
1
Muscle Weakness
1
1
Muscular Rigidity
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Arthrex, Inc.
II
Jul-21-2021
2
DePuy Mitek, Inc., a Johnson & Johnson Co.
II
Jun-02-2023
3
DePuy Mitek, Inc., a Johnson & Johnson Co.
II
Dec-10-2019
4
Smith & Nephew, Inc.
II
Apr-29-2021
5
Smith & Nephew, Inc.
II
Oct-21-2020
6
Smith & Nephew, Inc.
II
Apr-26-2018
-
-