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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
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
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 9
NUVASIVE SPECIALIZED ORTHOPEDICS, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 3
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 5
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
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 2
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 2517 2517
2020 3299 3299
2021 4111 4111
2022 2734 2803
2023 2232 2232
2024 2135 2135

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5595 5660
Break 3551 3551
Device-Device Incompatibility 2082 2082
Migration 1884 1888
Fracture 1318 1318
Migration or Expulsion of Device 333 333
Material Twisted/Bent 322 322
Material Deformation 258 258
Failure to Align 208 208
Mechanical Problem 184 184
Appropriate Term/Code Not Available 167 167
Patient Device Interaction Problem 136 136
Mechanical Jam 128 128
Connection Problem 120 120
Defective Device 117 117
Use of Device Problem 112 112
No Apparent Adverse Event 102 102
Detachment of Device or Device Component 101 101
Device Dislodged or Dislocated 98 98
Corroded 98 98
Separation Problem 93 93
Malposition of Device 91 91
Insufficient Information 91 91
Crack 78 78
Positioning Failure 73 73
Failure to Advance 70 70
Packaging Problem 68 68
Difficult to Advance 62 62
Physical Resistance/Sticking 62 62
Material Integrity Problem 58 58
Naturally Worn 52 52
Loosening of Implant Not Related to Bone-Ingrowth 50 50
Manufacturing, Packaging or Shipping Problem 49 49
Loose or Intermittent Connection 46 46
Material Discolored 43 43
Device Slipped 43 43
Material Fragmentation 42 42
Entrapment of Device 39 39
Difficult to Remove 36 36
Device Difficult to Setup or Prepare 34 34
Improper or Incorrect Procedure or Method 34 34
Incomplete or Inadequate Connection 33 33
Difficult to Insert 31 31
Unintended Movement 29 29
Delivered as Unsterile Product 27 27
Fitting Problem 26 26
Positioning Problem 25 25
Activation, Positioning or Separation Problem 25 25
Separation Failure 24 24
Deformation Due to Compressive Stress 23 23

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4064 4064
Failure of Implant 2433 2433
Non-union Bone Fracture 1651 1707
No Code Available 1565 1565
Pain 1260 1261
Bone Fracture(s) 1015 1015
Insufficient Information 1012 1016
Limb Fracture 909 909
No Consequences Or Impact To Patient 833 833
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 761 761
Injury 528 528
Unspecified Infection 501 501
No Known Impact Or Consequence To Patient 406 406
Implant Pain 400 410
Post Operative Wound Infection 369 369
No Patient Involvement 283 283
Impaired Healing 216 217
Foreign Body In Patient 199 199
Malunion of Bone 191 191
Hip Fracture 171 171
Physical Asymmetry 170 170
Necrosis 159 159
Unspecified Tissue Injury 153 153
Perforation 109 109
Ambulation Difficulties 104 104
Osteolysis 98 98
Discomfort 97 97
No Information 97 97
Fall 95 95
Loss of Range of Motion 82 88
Hematoma 77 77
Inflammation 62 62
Nerve Damage 55 56
Deformity/ Disfigurement 46 47
Swelling/ Edema 46 46
Wound Dehiscence 45 45
Device Embedded In Tissue or Plaque 44 44
Hypersensitivity/Allergic reaction 36 36
Ossification 36 36
Thrombosis/Thrombus 35 35
Arthritis 33 33
Unequal Limb Length 29 29
Joint Dislocation 29 29
Osteopenia/ Osteoporosis 27 27
Reaction 26 26
Joint Laxity 22 22
Osteomyelitis 21 21
Bacterial Infection 21 21
Death 20 20
Muscle/Tendon Damage 20 20

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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