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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
2
B-ONE ORTHO, CORP
SUBSTANTIALLY EQUIVALENT
1
CONMED CORPORATION
SUBSTANTIALLY EQUIVALENT
1
DEPUY MITEK
SUBSTANTIALLY EQUIVALENT
2
EMBODY, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDACTA INTERNATIONAL SA
SUBSTANTIALLY EQUIVALENT
1
MEDOS INTERNATIONAL SARL
SUBSTANTIALLY EQUIVALENT
2
NANOFIBER SOLUTIONS, LLC
SUBSTANTIALLY EQUIVALENT
4
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
1946
1946
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
4480
4480
Adverse Event Without Identified Device or Use Problem
918
918
Device-Device Incompatibility
473
473
Migration
288
288
Detachment of Device or Device Component
283
283
Crack
265
265
Material Deformation
264
264
Device Dislodged or Dislocated
227
227
Fracture
200
200
Difficult to Advance
135
135
Material Separation
124
124
Premature Activation
124
124
Material Twisted/Bent
98
98
Device Damaged Prior to Use
94
94
Material Split, Cut or Torn
90
90
Migration or Expulsion of Device
89
89
Positioning Failure
71
71
Insufficient Information
68
68
Failure to Advance
66
66
Mechanical Jam
64
64
Patient Device Interaction Problem
63
63
Defective Device
53
53
Entrapment of Device
49
49
Loose or Intermittent Connection
49
49
Unintended Movement
42
42
Material Frayed
40
40
Appropriate Term/Code Not Available
40
40
Physical Resistance/Sticking
40
40
Material Fragmentation
38
38
Use of Device Problem
35
35
Patient-Device Incompatibility
34
34
Difficult to Insert
33
33
Difficult to Remove
25
25
Loosening of Implant Not Related to Bone-Ingrowth
20
20
Device Contaminated During Manufacture or Shipping
20
20
Firing Problem
17
17
Delivered as Unsterile Product
17
17
Packaging Problem
17
17
Manufacturing, Packaging or Shipping Problem
17
17
Positioning Problem
16
16
Component Missing
13
13
Fitting Problem
13
13
Activation, Positioning or Separation Problem
12
12
Deformation Due to Compressive Stress
11
11
Mechanical Problem
11
11
Output Problem
9
9
Product Quality Problem
8
8
Unsealed Device Packaging
8
8
Biocompatibility
8
8
Device Slipped
8
8
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
4895
4895
No Consequences Or Impact To Patient
894
894
Insufficient Information
514
514
Unspecified Tissue Injury
398
398
Foreign Body In Patient
343
343
Not Applicable
307
307
Unspecified Infection
266
266
No Known Impact Or Consequence To Patient
170
170
No Code Available
160
160
Failure of Implant
159
159
Tissue Damage
157
157
Injury
156
156
Pain
148
148
No Information
133
133
Device Embedded In Tissue or Plaque
106
106
Inflammation
47
47
Perforation
44
44
Loss of Range of Motion
42
42
Hypersensitivity/Allergic reaction
42
42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
42
42
Rupture
41
41
Nerve Damage
34
34
Foreign Body Reaction
34
34
Swelling/ Edema
32
32
Joint Laxity
21
21
Impaired Healing
18
18
No Patient Involvement
16
16
Swelling
16
16
Post Operative Wound Infection
15
15
Damage to Ligament(s)
14
14
Abscess
13
13
Reaction
13
13
Fluid Discharge
13
13
Adhesion(s)
11
11
Hemorrhage/Bleeding
11
11
Joint Dislocation
11
11
Rash
10
10
Scar Tissue
10
10
Synovitis
9
9
Discomfort
9
9
Hematoma
9
9
Fever
9
9
Erythema
8
8
Cyst(s)
8
8
Sepsis
8
8
Bone Fracture(s)
7
7
Muscle/Tendon Damage
7
7
Bacterial Infection
6
6
Local Reaction
6
6
Osteolysis
6
6
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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