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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
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
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 7
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
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 1
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 2874 2874
2025 286 286

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5232 5297
Break 3113 3113
Device-Device Incompatibility 1914 1914
Migration 1810 1814
Fracture 1235 1235
Material Twisted/Bent 322 322
Migration or Expulsion of Device 294 294
Material Deformation 250 250
Failure to Align 208 208
Mechanical Problem 183 183
Patient Device Interaction Problem 138 138
Mechanical Jam 120 120
Connection Problem 106 106
Separation Problem 106 106
Corroded 98 98
Use of Device Problem 98 98
Malposition of Device 95 95
Detachment of Device or Device Component 95 95
Defective Device 89 89
Positioning Failure 88 88
Device Dislodged or Dislocated 78 78
Crack 76 76
No Apparent Adverse Event 75 75
Appropriate Term/Code Not Available 72 72
Failure to Advance 69 69
Physical Resistance/Sticking 69 69
Difficult to Advance 61 61
Material Integrity Problem 60 60
Insufficient Information 60 60
Loosening of Implant Not Related to Bone-Ingrowth 56 56
Naturally Worn 51 51
Manufacturing, Packaging or Shipping Problem 50 50
Material Discolored 45 45
Material Fragmentation 40 40
Device Difficult to Setup or Prepare 37 37
Device Slipped 37 37
Incomplete or Inadequate Connection 32 32
Entrapment of Device 31 31
Difficult to Remove 30 30
Loose or Intermittent Connection 30 30
Improper or Incorrect Procedure or Method 29 29
Device Damaged by Another Device 29 29
Contamination /Decontamination Problem 26 26
Separation Failure 25 25
Difficult to Insert 25 25
Deformation Due to Compressive Stress 23 23
Activation, Positioning or Separation Problem 23 23
Unintended Movement 22 22
Tear, Rip or Hole in Device Packaging 21 21
Fitting Problem 21 21

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4395 4395
Failure of Implant 2385 2385
Non-union Bone Fracture 1567 1623
Insufficient Information 1207 1211
Pain 1095 1095
Limb Fracture 1033 1033
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 761 761
Bone Fracture(s) 753 753
No Code Available 749 749
Implant Pain 450 460
Injury 423 423
Unspecified Infection 389 389
No Consequences Or Impact To Patient 384 384
Post Operative Wound Infection 353 353
No Known Impact Or Consequence To Patient 234 234
Malunion of Bone 210 210
Foreign Body In Patient 196 196
Physical Asymmetry 182 182
Impaired Healing 176 177
Unspecified Tissue Injury 168 168
Hip Fracture 166 166
No Patient Involvement 143 143
Necrosis 126 126
Perforation 119 119
Ambulation Difficulties 103 103
Osteolysis 94 94
Discomfort 91 91
Fall 89 89
Loss of Range of Motion 82 88
Hematoma 77 77
Swelling/ Edema 58 58
Inflammation 53 53
Wound Dehiscence 48 48
Nerve Damage 47 48
Deformity/ Disfigurement 45 46
No Information 43 43
Thrombosis/Thrombus 41 41
Ossification 38 38
Hypersensitivity/Allergic reaction 35 35
Device Embedded In Tissue or Plaque 33 33
Arthritis 31 31
Unequal Limb Length 26 26
Joint Dislocation 24 24
Joint Laxity 22 22
Osteopenia/ Osteoporosis 21 21
Osteomyelitis 21 21
Pulmonary Embolism 21 21
Muscle/Tendon Damage 20 20
Reaction 19 19
Bacterial Infection 18 18

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 Paragon 28, Inc. II Mar-05-2024
12 Smith & Nephew, Inc. II Aug-22-2023
13 Stryker GmbH II Jul-30-2021
14 Stryker GmbH II Jun-16-2020
15 Synthes (USA) Products LLC II Mar-01-2024
16 Synthes (USA) Products LLC II Mar-10-2023
17 Zimmer GmbH II Jun-04-2021
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