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TPLC
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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
12
ARTHREX, INC.
SUBSTANTIALLY EQUIVALENT
1
B-ONE ORTHO, CORP
SUBSTANTIALLY EQUIVALENT
1
CONMED CORPORATION
SUBSTANTIALLY EQUIVALENT
1
DEPUY MITEK
SUBSTANTIALLY EQUIVALENT
1
EMBODY, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDACTA INTERNATIONAL SA
SUBSTANTIALLY EQUIVALENT
1
MEDOS INTERNATIONAL SARL
SUBSTANTIALLY EQUIVALENT
2
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
SCIENCE & BIO MATERIALS (S.B.M.) SAS
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
SURGICAL FUSION TECHNOLOGIES GMBH
SUBSTANTIALLY EQUIVALENT
1
TEKNIMED
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
1247
1247
2020
957
957
2021
1267
1267
2022
1432
1432
2023
1720
1720
2024
740
740
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
3814
3814
Adverse Event Without Identified Device or Use Problem
862
862
Device-Device Incompatibility
425
425
Migration
241
241
Detachment of Device or Device Component
238
238
Crack
235
235
Material Deformation
217
217
Fracture
191
191
Device Dislodged or Dislocated
176
176
Material Separation
121
121
Difficult to Advance
91
91
Migration or Expulsion of Device
89
89
Material Twisted/Bent
88
88
Device Damaged Prior to Use
83
83
Material Split, Cut or Torn
81
81
Premature Activation
75
75
Insufficient Information
67
67
Mechanical Jam
55
55
Entrapment of Device
49
49
Loose or Intermittent Connection
49
49
Failure to Advance
47
47
Patient Device Interaction Problem
47
47
Positioning Failure
44
44
Defective Device
39
39
Material Fragmentation
37
37
Material Frayed
34
34
Patient-Device Incompatibility
34
34
Appropriate Term/Code Not Available
33
33
Difficult to Insert
30
30
Unintended Movement
29
29
Physical Resistance/Sticking
29
29
Difficult to Remove
25
25
Use of Device Problem
25
25
Device Contaminated During Manufacture or Shipping
19
19
Loosening of Implant Not Related to Bone-Ingrowth
17
17
Firing Problem
17
17
Delivered as Unsterile Product
17
17
Packaging Problem
16
16
Positioning Problem
16
16
Manufacturing, Packaging or Shipping Problem
15
15
Activation, Positioning or Separation Problem
12
12
Fitting Problem
12
12
Component Missing
11
11
Deformation Due to Compressive Stress
11
11
Mechanical Problem
10
10
Output Problem
9
9
Biocompatibility
8
8
Device Slipped
8
8
Product Quality Problem
7
7
Unsealed Device Packaging
7
7
Disconnection
6
6
Material Rupture
6
6
Unstable
6
6
Device Markings/Labelling Problem
6
6
Expulsion
6
6
Contamination /Decontamination Problem
5
5
Device Fell
5
5
Peeled/Delaminated
5
5
Flaked
5
5
Nonstandard Device
4
4
Unexpected Therapeutic Results
4
4
Expiration Date Error
4
4
Separation Failure
4
4
Material Integrity Problem
4
4
No Apparent Adverse Event
3
3
Misassembled During Installation
3
3
Device Damaged by Another Device
3
3
Failure to Fire
3
3
Improper or Incorrect Procedure or Method
3
3
Unraveled Material
3
3
Degraded
3
3
Difficult or Delayed Positioning
2
2
Component Incompatible
2
2
Misassembled
2
2
Failure to Osseointegrate
2
2
Device Appears to Trigger Rejection
2
2
Defective Component
2
2
Device Contamination with Body Fluid
2
2
Malposition of Device
2
2
Material Too Soft/Flexible
2
2
Component Misassembled
2
2
Program or Algorithm Execution Problem
2
2
Activation Problem
2
2
Scratched Material
2
2
Therapeutic or Diagnostic Output Failure
2
2
Material Protrusion/Extrusion
2
2
Connection Problem
2
2
Structural Problem
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Difficult to Open or Remove Packaging Material
1
1
Device Contamination with Chemical or Other Material
1
1
Installation-Related Problem
1
1
Naturally Worn
1
1
Device Handling Problem
1
1
Activation Failure
1
1
Noise, Audible
1
1
Separation Problem
1
1
Premature Separation
1
1
Intermittent Program or Algorithm Execution
1
1
Incomplete or Inadequate Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3931
3931
No Consequences Or Impact To Patient
894
894
Unspecified Tissue Injury
366
366
Insufficient Information
356
356
Not Applicable
307
307
Foreign Body In Patient
302
302
Unspecified Infection
248
248
No Known Impact Or Consequence To Patient
170
170
No Code Available
160
160
Tissue Damage
157
157
Injury
156
156
Pain
144
144
Failure of Implant
137
137
No Information
133
133
Device Embedded In Tissue or Plaque
100
100
Inflammation
46
46
Loss of Range of Motion
42
42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
42
42
Rupture
40
40
Hypersensitivity/Allergic reaction
38
38
Nerve Damage
32
32
Perforation
28
28
Foreign Body Reaction
26
26
Swelling/ Edema
25
25
Joint Laxity
18
18
No Patient Involvement
16
16
Swelling
16
16
Impaired Healing
14
14
Post Operative Wound Infection
14
14
Reaction
13
13
Abscess
13
13
Damage to Ligament(s)
12
12
Hemorrhage/Bleeding
11
11
Joint Dislocation
11
11
Fluid Discharge
11
11
Adhesion(s)
10
10
Rash
10
10
Scar Tissue
10
10
Fever
9
9
Hematoma
9
9
Erythema
8
8
Cyst(s)
8
8
Bone Fracture(s)
7
7
Muscle/Tendon Damage
7
7
Osteolysis
6
6
Bacterial Infection
6
6
Discomfort
6
6
Local Reaction
5
5
Synovitis
5
5
Staphylococcus Aureus
5
5
Purulent Discharge
5
5
Thrombosis/Thrombus
5
5
Numbness
4
4
Respiratory Failure
3
3
Joint Disorder
3
3
Tissue Breakdown
3
3
Fibrosis
3
3
Edema
3
3
Autoimmune Disorder
3
3
Death
3
3
Wound Dehiscence
3
3
Itching Sensation
3
3
Thrombus
3
3
Skin Discoloration
2
2
Renal Failure
2
2
Arthralgia
2
2
Ulcer
2
2
Urticaria
2
2
Weakness
2
2
Burning Sensation
2
2
Laceration(s)
2
2
Necrosis
2
2
Bruise/Contusion
2
2
Cellulitis
2
2
Headache
2
2
Osteopenia/ Osteoporosis
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
Ankylosis
1
1
Implant Pain
1
1
Skin Disorders
1
1
Subluxation
1
1
Limited Mobility Of The Implanted Joint
1
1
Patient Problem/Medical Problem
1
1
Skin Tears
1
1
Neck Stiffness
1
1
Skin Inflammation
1
1
Embolism
1
1
Fatigue
1
1
Pulmonary Embolism
1
1
Arthritis
1
1
Paralysis
1
1
Muscle Weakness
1
1
Muscular Rigidity
1
1
Nausea
1
1
Cramp(s)
1
1
Dizziness
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
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