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Device
fastener, fixation, biodegradable, soft tissue
Regulation Description
Single/multiple component metallic bone fixation appliances and accessories.
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
8
ARTHREX, INC.
SUBSTANTIALLY EQUIVALENT
3
B-ONE ORTHO, CORP
SUBSTANTIALLY EQUIVALENT
1
CONMED CORPORATION
SUBSTANTIALLY EQUIVALENT
1
DEPUY MITEK
SUBSTANTIALLY EQUIVALENT
3
EMBODY, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDACTA INTERNATIONAL SA
SUBSTANTIALLY EQUIVALENT
1
NANOFIBER SOLUTIONS, LLC
SUBSTANTIALLY EQUIVALENT
3
OSSIO LTD.
SUBSTANTIALLY EQUIVALENT
2
OSTEONIC CO., LTD.
SUBSTANTIALLY EQUIVALENT
4
PARCUS MEDICAL
SUBSTANTIALLY EQUIVALENT
1
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
2020
957
957
2021
1267
1267
2022
1431
1431
2023
1718
1718
2024
2303
2303
2025
453
453
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
4689
4689
Adverse Event Without Identified Device or Use Problem
688
688
Device-Device Incompatibility
475
475
Migration
296
296
Detachment of Device or Device Component
273
273
Material Deformation
259
259
Crack
246
246
Device Dislodged or Dislocated
244
244
Difficult to Advance
153
153
Premature Activation
121
121
Device Damaged Prior to Use
97
97
Fracture
82
82
Material Separation
70
70
Material Twisted/Bent
68
68
Mechanical Jam
59
59
Insufficient Information
58
58
Failure to Advance
57
57
Patient Device Interaction Problem
56
56
Positioning Failure
55
55
Defective Device
54
54
Physical Resistance/Sticking
50
50
Unintended Movement
47
47
Loose or Intermittent Connection
43
43
Migration or Expulsion of Device
43
43
Appropriate Term/Code Not Available
42
42
Entrapment of Device
41
41
Use of Device Problem
38
38
Material Split, Cut or Torn
37
37
Material Fragmentation
33
33
Difficult to Insert
25
25
Material Frayed
23
23
Device Contaminated During Manufacture or Shipping
20
20
Difficult to Remove
20
20
Delivered as Unsterile Product
17
17
Manufacturing, Packaging or Shipping Problem
17
17
Fitting Problem
16
16
Patient-Device Incompatibility
15
15
Packaging Problem
13
13
Positioning Problem
12
12
Output Problem
9
9
Loosening of Implant Not Related to Bone-Ingrowth
9
9
Unsealed Device Packaging
8
8
Product Quality Problem
7
7
Mechanical Problem
7
7
Device Slipped
6
6
Device Markings/Labelling Problem
6
6
Flaked
6
6
Unstable
6
6
Biocompatibility
6
6
Expulsion
6
6
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5613
5613
Insufficient Information
572
572
Unspecified Tissue Injury
403
403
No Consequences Or Impact To Patient
353
353
Foreign Body In Patient
336
336
Unspecified Infection
215
215
Failure of Implant
151
151
Not Applicable
100
100
Device Embedded In Tissue or Plaque
84
84
Pain
64
64
No Information
60
60
No Code Available
57
57
Perforation
55
55
No Known Impact Or Consequence To Patient
54
54
Injury
51
51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
42
42
Rupture
40
40
Tissue Damage
35
35
Swelling/ Edema
34
34
Nerve Damage
34
34
Hypersensitivity/Allergic reaction
32
32
Foreign Body Reaction
31
31
Inflammation
28
28
Joint Laxity
21
21
Impaired Healing
18
18
Loss of Range of Motion
16
16
No Patient Involvement
15
15
Post Operative Wound Infection
14
14
Damage to Ligament(s)
14
14
Fluid Discharge
12
12
Abscess
11
11
Hemorrhage/Bleeding
11
11
Synovitis
9
9
Adhesion(s)
8
8
Sepsis
8
8
Discomfort
8
8
Purulent Discharge
7
7
Cyst(s)
7
7
Muscle/Tendon Damage
7
7
Reaction
7
7
Rash
7
7
Joint Dislocation
6
6
Osteolysis
6
6
Swelling
6
6
Bone Fracture(s)
5
5
Local Reaction
5
5
Staphylococcus Aureus
5
5
Thrombosis/Thrombus
5
5
Hematoma
4
4
Implant Pain
4
4
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
Smith & Nephew, Inc.
II
Apr-29-2021
4
Smith & Nephew, Inc.
II
Oct-21-2020
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