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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device rod, fixation, intramedullary and accessories
Product CodeHSB
Regulation Number 888.3020
Device Class 2


Premarket Reviews
ManufacturerDecision
ADAPTABLE ORTHO INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
  1.  K221031  Arthrex DualCompression Hindfoot Fusion Nail Impla ...
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
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 2
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 709 709

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4965 5030
Break 3344 3344
Device-Device Incompatibility 1921 1921
Migration 1714 1718
Fracture 1204 1204
Migration or Expulsion of Device 331 331
Material Twisted/Bent 291 291
Material Deformation 248 248
Failure to Align 189 189
Mechanical Problem 180 180
Appropriate Term/Code Not Available 164 164
Patient Device Interaction Problem 133 133
Mechanical Jam 122 122
Connection Problem 120 120
Defective Device 112 112
Use of Device Problem 108 108
No Apparent Adverse Event 98 98
Detachment of Device or Device Component 91 91
Device Dislodged or Dislocated 90 90
Insufficient Information 87 87
Corroded 83 83
Malposition of Device 81 81
Crack 72 72
Separation Problem 71 71
Packaging Problem 68 68
Material Integrity Problem 57 57
Positioning Failure 55 55
Failure to Advance 54 54
Difficult to Advance 54 54
Naturally Worn 52 52
Loosening of Implant Not Related to Bone-Ingrowth 49 49
Loose or Intermittent Connection 46 46
Device Slipped 43 43
Physical Resistance/Sticking 40 40
Material Fragmentation 38 38
Entrapment of Device 36 36
Difficult to Remove 36 36
Incomplete or Inadequate Connection 33 33
Improper or Incorrect Procedure or Method 31 31
Difficult to Insert 29 29
Material Discolored 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
Activation, Positioning or Separation Problem 25 25
Fitting Problem 25 25
Unstable 22 22
Deformation Due to Compressive Stress 22 22
Material Protrusion/Extrusion 22 22
Separation Failure 21 21
Contamination /Decontamination Problem 19 19
Positioning Problem 18 18
Material Separation 18 18
Inadequacy of Device Shape and/or Size 18 18
Loss of Osseointegration 17 17
No Device Output 16 16
Defective Component 14 14
Device Damaged by Another Device 14 14
Patient-Device Incompatibility 13 13
Difficult or Delayed Separation 13 13
Tear, Rip or Hole in Device Packaging 12 12
Off-Label Use 11 11
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
Therapeutic or Diagnostic Output Failure 9 9
Inaccurate Information 9 9
Device Handling Problem 8 8
Output Problem 7 7
Failure to Disconnect 7 7
Device Markings/Labelling Problem 7 7
Device Damaged Prior to Use 7 7
Unsealed Device Packaging 7 7
Collapse 7 7
Unintended System Motion 7 7
Flaked 7 7
Failure to Osseointegrate 6 6
Mechanics Altered 6 6
Human-Device Interface Problem 6 6
Expulsion 5 5
Component Misassembled 5 5
Shipping Damage or Problem 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
Material Split, Cut or Torn 4 4
Device Fell 4 4
Misassembly by Users 4 4
Activation Problem 4 4
Misassembled During Installation 4 4
Installation-Related Problem 4 4
Biocompatibility 4 4
Scratched Material 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3692 3692
Failure of Implant 2227 2227
No Code Available 1565 1565
Non-union Bone Fracture 1517 1573
Pain 1101 1102
Bone Fracture(s) 980 980
No Consequences Or Impact To Patient 833 833
Insufficient Information 828 832
Limb Fracture 818 818
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 761 761
Injury 528 528
Unspecified Infection 470 470
No Known Impact Or Consequence To Patient 406 406
Post Operative Wound Infection 325 325
No Patient Involvement 283 283
Implant Pain 268 278
Foreign Body In Patient 181 181
Impaired Healing 177 178
Malunion of Bone 177 177
Hip Fracture 171 171
Physical Asymmetry 161 161
Necrosis 154 154
Unspecified Tissue Injury 142 142
Osteolysis 98 98
Ambulation Difficulties 97 97
No Information 97 97
Perforation 91 91
Fall 81 81
Discomfort 81 81
Hematoma 70 70
Loss of Range of Motion 60 66
Inflammation 59 59
Nerve Damage 50 51
Deformity/ Disfigurement 45 46
Device Embedded In Tissue or Plaque 43 43
Swelling/ Edema 39 39
Ossification 36 36
Hypersensitivity/Allergic reaction 34 34
Arthritis 31 31
Joint Dislocation 29 29
Osteopenia/ Osteoporosis 27 27
Thrombosis/Thrombus 27 27
Unequal Limb Length 26 26
Reaction 26 26
Wound Dehiscence 24 24
Joint Laxity 22 22
Abscess 20 20
Death 20 20
Pulmonary Embolism 18 18
Bacterial Infection 18 18
Irritation 18 18
Patient Problem/Medical Problem 18 18
Not Applicable 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
Embolism/Embolus 6 6
Localized Skin Lesion 6 6
Complaint, Ill-Defined 6 6
Numbness 6 6
Cancer 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
Thromboembolism 4 4
Needle Stick/Puncture 4 4
Fracture, Arm 4 4
Perforation of Vessels 4 4
Urinary Tract Infection 3 3
Spinal Column Injury 3 3
Ulcer 3 3
Urticaria 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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