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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
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
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
MEDSHAPE, INC.
  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
ORTHO SOLUTIONS UK LTD.
  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 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
PEGA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 7
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 4112
2022 2733 2802
2023 2219 2219
2024 2869 2869
2025 2425 2486

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6073 6164
Break 3541 3542
Device-Device Incompatibility 2171 2171
Migration 1941 1945
Fracture 1466 1466
Material Twisted/Bent 361 361
Migration or Expulsion of Device 295 295
Material Deformation 284 284
Failure to Align 263 263
Mechanical Problem 204 204
Patient Device Interaction Problem 154 154
Mechanical Jam 146 146
Positioning Failure 129 129
Separation Problem 124 130
Use of Device Problem 121 121
Detachment of Device or Device Component 117 118
Malposition of Device 116 116
Connection Problem 106 106
Defective Device 102 102
Corroded 101 101
Device Dislodged or Dislocated 98 98
No Apparent Adverse Event 87 87
Crack 84 84
Failure to Advance 78 78
Physical Resistance/Sticking 78 78
Appropriate Term/Code Not Available 73 73
Difficult to Advance 69 69
Loosening of Implant Not Related to Bone-Ingrowth 68 77
Insufficient Information 67 75
Material Integrity Problem 67 67
Manufacturing, Packaging or Shipping Problem 53 53
Naturally Worn 52 52
Material Discolored 48 48
Device Slipped 43 43
Device Damaged by Another Device 42 42
Device Difficult to Setup or Prepare 41 41
Material Fragmentation 40 40
Entrapment of Device 39 39
Improper or Incorrect Procedure or Method 36 36
Contamination /Decontamination Problem 34 34
Loose or Intermittent Connection 33 33
Difficult to Remove 33 33
Incomplete or Inadequate Connection 32 32
Difficult to Insert 27 27
Separation Failure 26 26
Unintended Movement 25 25
Deformation Due to Compressive Stress 24 24
Activation, Positioning or Separation Problem 23 23
Inadequacy of Device Shape and/or Size 22 34
Positioning Problem 22 22

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 5042 5042
Failure of Implant 2463 2469
Non-union Bone Fracture 1772 1829
Insufficient Information 1552 1577
Pain 1330 1335
Limb Fracture 1258 1258
Bone Fracture(s) 800 800
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 776 776
No Code Available 749 749
Implant Pain 601 611
Injury 423 423
Unspecified Infection 419 419
Post Operative Wound Infection 394 394
No Consequences Or Impact To Patient 384 384
No Known Impact Or Consequence To Patient 234 234
Foreign Body In Patient 227 227
Malunion of Bone 225 225
Impaired Healing 214 216
Physical Asymmetry 198 198
Unspecified Tissue Injury 174 174
Perforation 169 169
Hip Fracture 168 168
Necrosis 149 149
No Patient Involvement 143 143
Fall 117 117
Ambulation Difficulties 117 121
Loss of Range of Motion 95 101
Osteolysis 94 94
Discomfort 94 94
Hematoma 89 89
Swelling/ Edema 62 62
Inflammation 61 61
Wound Dehiscence 54 54
Thrombosis/Thrombus 50 50
Post Traumatic Wound Infection 49 49
Deformity/ Disfigurement 48 49
Nerve Damage 47 48
No Information 43 43
Hypersensitivity/Allergic reaction 42 42
Ossification 41 41
Arthritis 37 37
Device Embedded In Tissue or Plaque 35 35
Unequal Limb Length 27 27
Hemorrhage/Bleeding 26 26
Skin Inflammation/ Irritation 25 25
Muscle/Tendon Damage 25 25
Joint Dislocation 25 25
Osteopenia/ Osteoporosis 24 24
Joint Laxity 23 23
Metal Related Pathology 22 22

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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