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TPLC
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Device
rod, fixation, intramedullary and accessories
Product Code
HSB
Regulation Number
888.3020
Device Class
2
Premarket Reviews
Manufacturer
Decision
ADAPTABLE ORTHO INNOVATIONS, LLC
SUBSTANTIALLY EQUIVALENT
1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
2
ARTHREX INC.
SUBSTANTIALLY EQUIVALENT
1
ARTHREX, INC.
SUBSTANTIALLY EQUIVALENT
1
BAAT MEDICAL PRODUCTS BV
SUBSTANTIALLY EQUIVALENT
1
1. K201830
ANSER Clavicle Pin
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
SUBSTANTIALLY EQUIVALENT
1
CITIEFFE S.R.L.
SUBSTANTIALLY EQUIVALENT
2
CONVENTUS ORTHOPAEDICS, LLC
SUBSTANTIALLY EQUIVALENT
1
DOUBLE MEDICAL TECHNOLOGY INC.
SUBSTANTIALLY EQUIVALENT
1
FH INDUSTRIE
SUBSTANTIALLY EQUIVALENT
1
FLOW-FX, LLC
SUBSTANTIALLY EQUIVALENT
2
FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER
SUBSTANTIALLY EQUIVALENT
2
GLOBUS MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
GLW, INC.
SUBSTANTIALLY EQUIVALENT
2
GPC MEDICAL LIMITED
SUBSTANTIALLY EQUIVALENT
1
I.T.S. GMBH
SUBSTANTIALLY EQUIVALENT
1
INNOSYS
SUBSTANTIALLY EQUIVALENT
1
INTRAUMA S.P.A.
SUBSTANTIALLY EQUIVALENT
1
NEOORTHO PRODUTOS ORTOPÉDICOS S/A
SUBSTANTIALLY EQUIVALENT
1
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
SUBSTANTIALLY EQUIVALENT
9
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
ORTHO DEVELOPMENT CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ORTHOFIX SRL
SUBSTANTIALLY EQUIVALENT
1
ORTHOPEDIATRICS CORP.
SUBSTANTIALLY EQUIVALENT
2
ORTHOPEDIATRICS, CORP.
SUBSTANTIALLY EQUIVALENT
1
ORTHOXEL DAC
SUBSTANTIALLY EQUIVALENT
1
PARAGON 28, INC
SUBSTANTIALLY EQUIVALENT
1
PARAGON 28, INC.
SUBSTANTIALLY EQUIVALENT
4
PEGA MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
2
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
STRYKER GMBH
SUBSTANTIALLY EQUIVALENT
5
STRYKER TRAUMA GMBH
SUBSTANTIALLY EQUIVALENT
3
SYNTEC SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
3
SYNTHES (USA) PRODUCTS, LLC
SUBSTANTIALLY EQUIVALENT
1
TORNIER, INC.
SUBSTANTIALLY EQUIVALENT
1
VILEX LLC
SUBSTANTIALLY EQUIVALENT
1
WITTENSTEIN INTENS GMBH
SUBSTANTIALLY EQUIVALENT
1
X-BOLT ORTHOPEDICS
SUBSTANTIALLY EQUIVALENT
1
ZIMMER GMBH
SUBSTANTIALLY EQUIVALENT
2
ZIMMER SWITZERLAND MANUFACTURING GMBH
SUBSTANTIALLY EQUIVALENT
1
ZIMMER, INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
2516
2516
2020
3299
3299
2021
4111
4111
2022
2726
2795
2023
2232
2232
2024
537
537
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
4923
4988
Break
3299
3299
Device-Device Incompatibility
1900
1900
Migration
1706
1710
Fracture
1179
1179
Migration or Expulsion of Device
328
328
Material Twisted/Bent
284
284
Material Deformation
247
247
Failure to Align
184
184
Mechanical Problem
176
176
Appropriate Term/Code Not Available
164
164
Patient Device Interaction Problem
133
133
Mechanical Jam
121
121
Connection Problem
119
119
Defective Device
109
109
Use of Device Problem
106
106
No Apparent Adverse Event
97
97
Device Dislodged or Dislocated
90
90
Detachment of Device or Device Component
89
89
Insufficient Information
86
86
Corroded
83
83
Malposition of Device
76
76
Crack
72
72
Separation Problem
71
71
Packaging Problem
68
68
Material Integrity Problem
57
57
Positioning Failure
55
55
Difficult to Advance
53
53
Naturally Worn
52
52
Failure to Advance
51
51
Loosening of Implant Not Related to Bone-Ingrowth
47
47
Loose or Intermittent Connection
46
46
Device Slipped
43
43
Physical Resistance/Sticking
40
40
Material Fragmentation
37
37
Entrapment of Device
36
36
Difficult to Remove
36
36
Incomplete or Inadequate Connection
33
33
Improper or Incorrect Procedure or Method
31
31
Material Discolored
29
29
Difficult to Insert
29
29
Manufacturing, Packaging or Shipping Problem
29
29
Device Difficult to Setup or Prepare
28
28
Delivered as Unsterile Product
27
27
Unintended Movement
26
26
Fitting Problem
25
25
Unstable
22
22
Material Protrusion/Extrusion
22
22
Activation, Positioning or Separation Problem
22
22
Deformation Due to Compressive Stress
21
21
Separation Failure
20
20
Contamination /Decontamination Problem
19
19
Inadequacy of Device Shape and/or Size
18
18
Material Separation
18
18
Loss of Osseointegration
17
17
Positioning Problem
17
17
No Device Output
16
16
Defective Component
14
14
Device Damaged by Another Device
13
13
Patient-Device Incompatibility
13
13
Difficult or Delayed Separation
13
13
Tear, Rip or Hole in Device Packaging
12
12
Device Contaminated During Manufacture or Shipping
11
11
Osseointegration Problem
10
10
Device Difficult to Maintain
10
10
Off-Label Use
10
10
Degraded
10
10
Difficult or Delayed Positioning
9
9
Component Missing
9
9
Inaccurate Information
9
9
Therapeutic or Diagnostic Output Failure
9
9
Device Handling Problem
8
8
Output Problem
7
7
Device Markings/Labelling Problem
7
7
Device Damaged Prior to Use
7
7
Failure to Disconnect
7
7
Unsealed Device Packaging
7
7
Collapse
7
7
Flaked
7
7
Unintended System Motion
6
6
Failure to Osseointegrate
6
6
Human-Device Interface Problem
6
6
Mechanics Altered
5
5
Expulsion
5
5
Component Misassembled
5
5
Peeled/Delaminated
5
5
Product Quality Problem
5
5
Residue After Decontamination
5
5
Disconnection
5
5
Material Erosion
4
4
Dull, Blunt
4
4
Shipping Damage or Problem
4
4
Material Split, Cut or Torn
4
4
Activation Problem
4
4
Device Fell
4
4
Misassembly by Users
4
4
Misassembled During Installation
4
4
Installation-Related Problem
4
4
Scratched Material
3
3
Noise, Audible
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3632
3632
Failure of Implant
2189
2189
No Code Available
1565
1565
Non-union Bone Fracture
1498
1554
Pain
1099
1100
Bone Fracture(s)
977
977
No Consequences Or Impact To Patient
833
833
Insufficient Information
804
808
Limb Fracture
794
794
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
761
761
Injury
528
528
Unspecified Infection
466
466
No Known Impact Or Consequence To Patient
406
406
Post Operative Wound Infection
321
321
No Patient Involvement
283
283
Implant Pain
262
272
Impaired Healing
177
178
Foreign Body In Patient
175
175
Malunion of Bone
173
173
Hip Fracture
171
171
Physical Asymmetry
160
160
Necrosis
151
151
Unspecified Tissue Injury
139
139
Osteolysis
98
98
No Information
97
97
Ambulation Difficulties
95
95
Perforation
88
88
Fall
81
81
Discomfort
78
78
Hematoma
70
70
Loss of Range of Motion
60
66
Inflammation
58
58
Nerve Damage
50
51
Deformity/ Disfigurement
45
46
Device Embedded In Tissue or Plaque
43
43
Swelling/ Edema
39
39
Ossification
35
35
Arthritis
31
31
Hypersensitivity/Allergic reaction
31
31
Joint Dislocation
29
29
Osteopenia/ Osteoporosis
27
27
Reaction
26
26
Wound Dehiscence
24
24
Thrombosis/Thrombus
24
24
Unequal Limb Length
23
23
Joint Laxity
22
22
Abscess
20
20
Death
20
20
Pulmonary Embolism
18
18
Bacterial Infection
18
18
Irritation
18
18
Not Applicable
18
18
Patient Problem/Medical Problem
18
18
Fatigue
16
16
Osteomyelitis
16
16
Tissue Damage
15
15
Hemorrhage/Bleeding
14
14
Therapeutic Response, Decreased
13
13
Skin Inflammation/ Irritation
13
13
Metal Related Pathology
12
12
Muscle/Tendon Damage
12
12
Paralysis
12
12
Sepsis
12
12
Muscular Rigidity
11
11
Cyst(s)
11
11
Skin Irritation
11
11
Blood Loss
11
11
Thrombosis
10
10
Calcium Deposits/Calcification
9
9
Laceration(s)
8
8
Inadequate Osseointegration
8
8
Respiratory Failure
7
7
Seroma
7
7
Unspecified Musculoskeletal problem
7
7
Localized Skin Lesion
6
6
Complaint, Ill-Defined
6
6
Numbness
6
6
Cancer
6
6
Embolism/Embolus
6
6
Fistula
6
6
Erythema
6
6
Stroke/CVA
5
5
Cardiopulmonary Arrest
5
5
Erosion
5
5
Cellulitis
4
4
Abrasion
4
4
Adhesion(s)
4
4
Cardiac Arrest
4
4
Myocardial Infarction
4
4
Pulmonary Edema
4
4
Neuropathy
4
4
Fibrosis
4
4
Needle Stick/Puncture
4
4
Thromboembolism
4
4
Fracture, Arm
4
4
Perforation of Vessels
4
4
Urinary Tract Infection
3
3
Spinal Column Injury
3
3
Ulcer
3
3
Respiratory Tract Infection
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Jan-27-2023
2
Biomet, Inc.
II
Dec-17-2020
3
Flower Orthopedics Corporation
II
Oct-06-2023
4
Flower Orthopedics Corporation
II
Jan-03-2022
5
Merete Medical GmbH
II
Nov-06-2020
6
NuVasive Specialized Orthopedics, Inc.
II
Dec-01-2021
7
Nuvasive Specialized Orthopedics Inc
II
Apr-05-2021
8
Nuvasive Specialized Orthopedics Inc
II
Mar-30-2021
9
Nuvasive Specialized Orthopedics Inc
II
Oct-07-2020
10
OrthoPediatrics Corp
II
Oct-25-2019
11
OrthoPediatrics Corp
II
Oct-13-2019
12
Paragon 28, Inc.
II
Mar-05-2024
13
Pega Medical Inc.
II
Aug-14-2019
14
Smith & Nephew, Inc.
II
Aug-22-2023
15
Stryker GmbH
II
Jul-30-2021
16
Stryker GmbH
II
Jun-16-2020
17
Synthes (USA) Products LLC
II
Mar-01-2024
18
Synthes (USA) Products LLC
II
Mar-10-2023
19
Wright Medical Technology, Inc.
II
Nov-25-2019
20
Zimmer Biomet, Inc.
II
Nov-07-2019
21
Zimmer GmbH
II
Jun-04-2021
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