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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
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
ORTHOPEDIATRICS CORP.
SUBSTANTIALLY EQUIVALENT
2
ORTHOPEDIATRICS, CORP.
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
349
349
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
4884
4949
Break
3255
3255
Device-Device Incompatibility
1862
1862
Migration
1687
1691
Fracture
1150
1150
Migration or Expulsion of Device
328
328
Material Twisted/Bent
273
273
Material Deformation
244
244
Failure to Align
182
182
Mechanical Problem
173
173
Appropriate Term/Code Not Available
164
164
Patient Device Interaction Problem
131
131
Mechanical Jam
121
121
Connection Problem
119
119
Defective Device
107
107
Use of Device Problem
103
103
No Apparent Adverse Event
97
97
Device Dislodged or Dislocated
90
90
Insufficient Information
85
85
Detachment of Device or Device Component
84
84
Corroded
83
83
Malposition of Device
76
76
Crack
70
70
Separation Problem
69
69
Packaging Problem
68
68
Positioning Failure
55
55
Material Integrity Problem
54
54
Naturally Worn
52
52
Difficult to Advance
52
52
Failure to Advance
48
48
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
Difficult to Remove
36
36
Entrapment of Device
33
33
Incomplete or Inadequate Connection
33
33
Improper or Incorrect Procedure or Method
31
31
Difficult to Insert
29
29
Manufacturing, Packaging or Shipping Problem
29
29
Device Difficult to Setup or Prepare
28
28
Delivered as Unsterile Product
26
26
Unintended Movement
26
26
Material Discolored
25
25
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
19
19
Inadequacy of Device Shape and/or Size
18
18
Material Separation
18
18
Contamination /Decontamination Problem
18
18
Positioning Problem
17
17
Loss of Osseointegration
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
Degraded
10
10
Difficult or Delayed Positioning
9
9
Component Missing
9
9
Off-Label Use
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
Unsealed Device Packaging
7
7
Device Damaged Prior to Use
7
7
Failure to Disconnect
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
Peeled/Delaminated
5
5
Residue After Decontamination
5
5
Disconnection
5
5
Material Erosion
4
4
Dull, Blunt
4
4
Product Quality Problem
4
4
Installation-Related Problem
4
4
Misassembly by Users
4
4
Activation Problem
4
4
Device Fell
4
4
Component Misassembled
4
4
Material Split, Cut or Torn
4
4
Misassembled During Installation
4
4
Noise, Audible
3
3
Scratched Material
3
3
Shipping Damage or Problem
3
3
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
3568
3568
Failure of Implant
2172
2172
No Code Available
1565
1565
Non-union Bone Fracture
1489
1545
Pain
1084
1085
Bone Fracture(s)
973
973
No Consequences Or Impact To Patient
833
833
Limb Fracture
772
772
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
761
761
Insufficient Information
755
759
Injury
528
528
Unspecified Infection
460
460
No Known Impact Or Consequence To Patient
406
406
Post Operative Wound Infection
317
317
No Patient Involvement
283
283
Implant Pain
258
268
Impaired Healing
177
178
Malunion of Bone
172
172
Hip Fracture
171
171
Foreign Body In Patient
164
164
Physical Asymmetry
158
158
Necrosis
146
146
Unspecified Tissue Injury
137
137
No Information
97
97
Osteolysis
95
95
Ambulation Difficulties
93
93
Perforation
87
87
Discomfort
77
77
Fall
75
75
Hematoma
68
68
Loss of Range of Motion
60
66
Inflammation
58
58
Nerve Damage
49
50
Deformity/ Disfigurement
45
46
Device Embedded In Tissue or Plaque
43
43
Swelling/ Edema
38
38
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
23
23
Unequal Limb Length
23
23
Joint Laxity
21
21
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
Embolism/Embolus
6
6
Fistula
6
6
Erythema
6
6
Stroke/CVA
5
5
Cardiopulmonary Arrest
5
5
Erosion
5
5
Cancer
5
5
Fibrosis
4
4
Needle Stick/Puncture
4
4
Fracture, Arm
4
4
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
Oversedation
3
3
Scar Tissue
3
3
Foreign Body Reaction
3
3
Purulent Discharge
3
3
Dysphagia/ Odynophagia
3
3
Ulcer
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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