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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
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 5
CHANGZHOU GEASURE MEDICAL APPARATUS AND INSTRUMENTS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE S.R.L.
  SUBSTANTIALLY EQUIVALENT 1
CONVENTUS ORTHOPAEDICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
DEPUY SYNTHES
  SUBSTANTIALLY EQUIVALENT 1
DOUBLE MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLOW-FX, LLC
  SUBSTANTIALLY EQUIVALENT 2
FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER
  SUBSTANTIALLY EQUIVALENT 2
FUSION ORTHOPEDICS USA, LLC
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
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 2
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 1
NEOORTHO PRODUTOS ORTOPÉDICOS S/A
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHO SOLUTIONS UK , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 5
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 1
RESELUTE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SATORI ORTHOPAEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 7
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 SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 2
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2021 4111 4129
2022 2733 2839
2023 2219 2240
2024 2869 2891
2025 2933 2994
2026 747 747

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5165 5279
Break 3160 3193
Device-Device Incompatibility 1979 1993
Migration 1724 1738
Fracture 1412 1427
Material Twisted/Bent 380 383
Failure to Align 287 288
Material Deformation 278 278
Migration or Expulsion of Device 259 263
Mechanical Problem 176 176
Positioning Failure 170 170
Patient Device Interaction Problem 162 163
Mechanical Jam 152 153
Malposition of Device 143 143
Detachment of Device or Device Component 114 117
Use of Device Problem 105 105
Crack 91 91
Device Dislodged or Dislocated 90 90
Separation Problem 90 96
Physical Resistance/Sticking 89 89
Failure to Advance 89 89
Corroded 86 86
No Apparent Adverse Event 73 73
Loosening of Implant Not Related to Bone-Ingrowth 72 82
Difficult to Advance 65 66
Connection Problem 62 62
Material Integrity Problem 59 59
Insufficient Information 56 64
Device Difficult to Setup or Prepare 56 56
Defective Device 53 53
Device Damaged by Another Device 53 53
Manufacturing, Packaging or Shipping Problem 51 51
Naturally Worn 47 47
Material Discolored 45 45
Device Slipped 41 41
Improper or Incorrect Procedure or Method 41 41
Entrapment of Device 39 39
Contamination /Decontamination Problem 39 39
Material Fragmentation 34 34
Appropriate Term/Code Not Available 30 30
Difficult to Remove 28 29
Loose or Intermittent Connection 25 25
Separation Failure 24 24
Biocompatibility 23 23
Deformation Due to Compressive Stress 23 23
Tear, Rip or Hole in Device Packaging 21 21
Off-Label Use 20 21
Positioning Problem 20 20
Unintended Movement 19 19
Difficult to Insert 19 19

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5331 5371
Failure of Implant 1876 1905
Insufficient Information 1757 1788
Non-union Bone Fracture 1571 1638
Limb Fracture 1371 1371
Pain 1250 1273
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 746 755
Implant Pain 576 587
Bone Fracture(s) 495 497
Unspecified Infection 351 356
Post Operative Wound Infection 328 328
Physical Asymmetry 210 214
Foreign Body In Patient 207 207
Perforation 198 198
Impaired Healing 173 176
Necrosis 171 177
Unspecified Tissue Injury 170 170
Malunion of Bone 166 166
Loss of Range of Motion 123 130
Ambulation Difficulties 115 119
Fall 114 115
Hip Fracture 98 99
Discomfort 79 80
Hematoma 69 70
Swelling/ Edema 63 63
Inflammation 62 64
Osteolysis 51 51
Wound Dehiscence 50 50
Post Traumatic Wound Infection 49 49
Thrombosis/Thrombus 48 48
Hypersensitivity/Allergic reaction 46 46
Nerve Damage 44 45
Deformity/ Disfigurement 39 40
Ossification 28 28
Arthritis 27 27
Hemorrhage/Bleeding 27 27
Joint Dislocation 26 26
Muscle/Tendon Damage 25 25
Skin Inflammation/ Irritation 25 25
Device Embedded In Tissue or Plaque 25 26
Joint Laxity 23 23
Metal Related Pathology 22 23
Pulmonary Embolism 20 20
Osteomyelitis 19 19
Osteopenia/ Osteoporosis 18 18
Fatigue 16 16
Unequal Limb Length 16 16
Abscess 14 18
Bacterial Infection 14 14
Sepsis 13 13

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Jan-27-2023
2 Flower Orthopedics Corporation II Oct-06-2023
3 Flower Orthopedics Corporation II Jan-03-2022
4 NuVasive Specialized Orthopedics, Inc. II Nov-21-2024
5 NuVasive Specialized Orthopedics, Inc. II Dec-01-2021
6 Nuvasive Specialized Orthopedics Inc II Apr-05-2021
7 Nuvasive Specialized Orthopedics Inc II Mar-30-2021
8 Orthofix Srl II Jun-13-2025
9 Paragon 28, Inc. II Dec-02-2025
10 Paragon 28, Inc. II Mar-05-2024
11 Smith & Nephew, Inc. II May-19-2025
12 Smith & Nephew, Inc. II Aug-22-2023
13 Stryker GmbH II Jun-10-2025
14 Stryker GmbH II Jun-06-2025
15 Stryker GmbH II Jul-30-2021
16 Synthes (USA) Products LLC II Mar-01-2024
17 Synthes (USA) Products LLC II Mar-10-2023
18 Zimmer GmbH II Jun-04-2021
19 Zimmer, Inc. II Dec-22-2025
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