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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
Regulation Description Intramedullary fixation rod.
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 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 2
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAAT MEDICAL PRODUCTS BV
  SUBSTANTIALLY EQUIVALENT 1
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
CONVENTUS ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES
  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
GM DOS REIS INDUSTRIA E COMERCIO
  SUBSTANTIALLY EQUIVALENT 1
GPC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
I.T.S. GMBH
  SUBSTANTIALLY EQUIVALENT 1
INNOSYS
  SUBSTANTIALLY EQUIVALENT 1
INTRAUMA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
JEIL MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
NEOORTHO PRODUTOS ORTOPÉDICOS S/A
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 7
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 4
ORTHOPEDIATRICS CANADA ULC DBA PEGA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPEDIC DESIGNS NORTH AMERICA, INC. (ODI-NA)
  SUBSTANTIALLY EQUIVALENT 1
ORTHOXEL DAC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
PEGA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 5
STRYKER TRAUMA GMBH
  SUBSTANTIALLY EQUIVALENT 2
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
TDM CO., LTD.
  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 1
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3299 3299
2021 4111 4111
2022 2734 2803
2023 2232 2232
2024 2876 2876
2025 1053 1059

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5450 5515
Break 3294 3294
Device-Device Incompatibility 2026 2026
Migration 1860 1864
Fracture 1330 1330
Material Twisted/Bent 338 338
Migration or Expulsion of Device 295 295
Material Deformation 260 260
Failure to Align 228 228
Mechanical Problem 196 196
Patient Device Interaction Problem 150 150
Mechanical Jam 134 134
Detachment of Device or Device Component 110 110
Separation Problem 110 116
Positioning Failure 109 109
Connection Problem 106 106
Use of Device Problem 105 105
Malposition of Device 103 103
Defective Device 99 99
Corroded 98 98
Device Dislodged or Dislocated 91 91
No Apparent Adverse Event 80 80
Crack 77 77
Appropriate Term/Code Not Available 73 73
Physical Resistance/Sticking 73 73
Failure to Advance 71 71
Difficult to Advance 66 66
Loosening of Implant Not Related to Bone-Ingrowth 64 64
Insufficient Information 63 63
Material Integrity Problem 62 62
Manufacturing, Packaging or Shipping Problem 52 52
Naturally Worn 51 51
Material Discolored 45 45
Material Fragmentation 40 40
Device Slipped 39 39
Device Difficult to Setup or Prepare 39 39
Entrapment of Device 36 36
Device Damaged by Another Device 34 34
Loose or Intermittent Connection 33 33
Incomplete or Inadequate Connection 32 32
Improper or Incorrect Procedure or Method 32 32
Difficult to Remove 32 32
Contamination /Decontamination Problem 29 29
Separation Failure 26 26
Difficult to Insert 26 26
Deformation Due to Compressive Stress 24 24
Activation, Positioning or Separation Problem 23 23
Unintended Movement 22 22
Tear, Rip or Hole in Device Packaging 21 21
Positioning Problem 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4662 4662
Failure of Implant 2440 2446
Non-union Bone Fracture 1631 1687
Insufficient Information 1344 1348
Pain 1158 1158
Limb Fracture 1142 1142
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 773 773
Bone Fracture(s) 771 771
No Code Available 749 749
Implant Pain 458 468
Injury 423 423
Unspecified Infection 406 406
No Consequences Or Impact To Patient 384 384
Post Operative Wound Infection 362 362
No Known Impact Or Consequence To Patient 234 234
Malunion of Bone 218 218
Foreign Body In Patient 213 213
Physical Asymmetry 191 191
Impaired Healing 179 180
Unspecified Tissue Injury 174 174
Hip Fracture 166 166
No Patient Involvement 143 143
Perforation 140 140
Necrosis 133 133
Ambulation Difficulties 113 113
Discomfort 94 94
Osteolysis 94 94
Fall 93 93
Loss of Range of Motion 87 93
Hematoma 85 85
Swelling/ Edema 61 61
Inflammation 61 61
Wound Dehiscence 48 48
Nerve Damage 47 48
Thrombosis/Thrombus 45 45
Deformity/ Disfigurement 45 46
No Information 43 43
Ossification 38 38
Hypersensitivity/Allergic reaction 35 35
Arthritis 33 33
Device Embedded In Tissue or Plaque 33 33
Hemorrhage/Bleeding 26 26
Unequal Limb Length 26 26
Muscle/Tendon Damage 25 25
Joint Dislocation 24 24
Osteopenia/ Osteoporosis 23 23
Joint Laxity 23 23
Pulmonary Embolism 22 22
Skin Inflammation/ Irritation 22 22
Metal Related Pathology 21 21

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 Nov-21-2024
7 NuVasive Specialized Orthopedics, Inc. II Dec-01-2021
8 Nuvasive Specialized Orthopedics Inc II Apr-05-2021
9 Nuvasive Specialized Orthopedics Inc II Mar-30-2021
10 Nuvasive Specialized Orthopedics Inc II Oct-07-2020
11 Orthofix Srl II Jun-13-2025
12 Paragon 28, Inc. II Mar-05-2024
13 Smith & Nephew, Inc. II May-19-2025
14 Smith & Nephew, Inc. II Aug-22-2023
15 Stryker GmbH II Jun-10-2025
16 Stryker GmbH II Jun-06-2025
17 Stryker GmbH II Jul-30-2021
18 Stryker GmbH II Jun-16-2020
19 Synthes (USA) Products LLC II Mar-01-2024
20 Synthes (USA) Products LLC II Mar-10-2023
21 Zimmer GmbH II Jun-04-2021
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