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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
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX INC.
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAAT MEDICAL PRODUCTS BV
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  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
DOUBLE MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 2
FH INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 1
FLOW-FX, LLC
  SUBSTANTIALLY EQUIVALENT 1
FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
GLW, INC.
  SUBSTANTIALLY EQUIVALENT 2
GPC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 1
INNOSYS
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRAFUSE LLC
  SUBSTANTIALLY EQUIVALENT 2
INTRAUMA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MEDSHAPE, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERETE GMBH
  SUBSTANTIALLY EQUIVALENT 1
NEOORTHO PRODUTOS ORTOPÉDICOS S/A
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 16
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOPEDIATRICS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOXEL
  SUBSTANTIALLY EQUIVALENT 2
PARAGON 28, INC
  SUBSTANTIALLY EQUIVALENT 1
PARAGON 28, INC.
  SUBSTANTIALLY EQUIVALENT 4
PEGA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
SIGN FRACTURE CARE INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 1
SONOMA ORTHOPEDIC PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 5
STRYKER TRAUMA GMBH
  SUBSTANTIALLY EQUIVALENT 5
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
  1.  K161327  SYNTEC HUMERAL NAIL SYSTEM
  2.  K181296  Syntec Femoral Nail System
  3.  K191617  Syntec Tibial Nail System
  4.  K202935  Syntec Femoral Nail Extended System
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
THE ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TORNIER, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
WITTENSTEIN INTENS GMBH
  SUBSTANTIALLY EQUIVALENT 2
X-BOLT ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
X-BOLT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1447 1447
2018 3526 3526
2019 2516 2516
2020 3299 3299
2021 4111 4111
2022 2726 2795
2023 2048 2048

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5828 5893
Break 3959 3959
Device-Device Incompatibility 1922 1922
Migration 1682 1686
Fracture 1419 1419
Appropriate Term/Code Not Available 570 570
Migration or Expulsion of Device 509 509
Insufficient Information 425 425
Material Twisted/Bent 276 276
Packaging Problem 273 273
Device Contaminated During Manufacture or Shipping 269 269
Failure to Align 267 267
Device Operates Differently Than Expected 260 260
Material Deformation 252 252
Mechanical Problem 219 219
Delivered as Unsterile Product 194 194
Mechanical Jam 178 178
Unintended Movement 144 144
Patient Device Interaction Problem 133 133
Connection Problem 125 125
Use of Device Problem 116 116
Defective Device 111 111
Device Dislodged or Dislocated 106 106
Malposition of Device 96 96
No Apparent Adverse Event 95 95
Crack 84 84
Detachment of Device or Device Component 83 83
Material Discolored 79 79
Corroded 76 76
Difficult to Remove 67 67
Separation Problem 67 67
Fitting Problem 66 66
Material Integrity Problem 64 64
Difficult to Advance 59 59
Naturally Worn 57 57
Loose or Intermittent Connection 57 57
Difficult to Insert 57 57
Positioning Failure 54 54
Device Slipped 54 54
Failure to Advance 51 51
Improper or Incorrect Procedure or Method 47 47
Material Fragmentation 46 46
Contamination /Decontamination Problem 45 45
Loosening of Implant Not Related to Bone-Ingrowth 44 44
Physical Resistance/Sticking 39 39
Positioning Problem 37 37
Entrapment of Device 36 36
Unsealed Device Packaging 35 35
Incomplete or Inadequate Connection 33 33
Patient-Device Incompatibility 32 32
Manufacturing, Packaging or Shipping Problem 31 31
Device Difficult to Setup or Prepare 27 27
Inadequacy of Device Shape and/or Size 27 27
Unstable 26 26
Failure to Osseointegrate 26 26
Activation, Positioning or Separation Problem 25 25
Tear, Rip or Hole in Device Packaging 25 25
Material Protrusion/Extrusion 23 23
Component Missing 21 21
Material Separation 21 21
Failure To Adhere Or Bond 21 21
Deformation Due to Compressive Stress 20 20
Loss of Osseointegration 19 19
Loss of or Failure to Bond 19 19
Bent 18 18
Detachment Of Device Component 18 18
Separation Failure 18 18
Dent in Material 17 17
Device Packaging Compromised 16 16
No Device Output 16 16
Disassembly 14 14
Device Damaged by Another Device 14 14
Device Markings/Labelling Problem 14 14
Defective Component 14 14
Device Difficult to Maintain 14 14
Difficult or Delayed Separation 13 13
Device Contamination with Chemical or Other Material 13 13
Mechanics Altered 12 12
Osseointegration Problem 11 11
Out-Of-Box Failure 11 11
Off-Label Use 11 11
Sticking 11 11
Device Handling Problem 11 11
Activation Failure 11 11
Inflation Problem 10 10
Degraded 10 10
Collapse 10 10
Difficult or Delayed Positioning 9 9
Flaked 9 9
Device Inoperable 9 9
Difficult To Position 9 9
Incomplete or Missing Packaging 9 9
Device Damaged Prior to Use 9 9
Failure to Disconnect 9 9
Therapeutic or Diagnostic Output Failure 9 9
Inaccurate Information 9 9
Misassembled 8 8
Output Problem 7 7
Protective Measures Problem 7 7
Installation-Related Problem 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3391 3391
No Code Available 2669 2669
Failure of Implant 2602 2602
Non-union Bone Fracture 1772 1828
Pain 1582 1583
Bone Fracture(s) 1481 1481
No Consequences Or Impact To Patient 1088 1088
No Known Impact Or Consequence To Patient 1021 1021
No Patient Involvement 973 973
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 757 757
Limb Fracture 708 708
Insufficient Information 667 671
Unspecified Infection 656 656
Injury 607 607
Post Operative Wound Infection 334 334
No Information 329 329
Impaired Healing 296 297
Death 265 265
Implant Pain 247 257
Hip Fracture 207 207
Foreign Body In Patient 178 178
Malunion of Bone 173 173
Necrosis 161 161
Physical Asymmetry 157 157
Unspecified Tissue Injury 132 132
Discomfort 109 109
Fall 100 100
Ambulation Difficulties 99 99
Osteolysis 94 94
Perforation 89 89
Device Embedded In Tissue or Plaque 89 89
Hematoma 73 73
Loss of Range of Motion 69 75
Nerve Damage 65 66
Inflammation 59 59
Not Applicable 56 56
Tissue Damage 50 50
Arthritis 48 48
Irritation 46 46
Deformity/ Disfigurement 42 43
Ossification 41 41
Swelling/ Edema 35 35
Reaction 34 34
Joint Dislocation 33 33
Hypersensitivity/Allergic reaction 32 32
Osteopenia/ Osteoporosis 28 28
Bacterial Infection 26 26
Wound Dehiscence 25 25
Patient Problem/Medical Problem 25 25
Unequal Limb Length 23 23
Pulmonary Embolism 21 21
Thrombosis/Thrombus 20 20
Complaint, Ill-Defined 19 19
Inadequate Osseointegration 18 18
Skin Irritation 17 17
Abscess 17 17
Fatigue 17 17
Thrombosis 16 16
Sepsis 15 15
Joint Laxity 15 15
Osteomyelitis 14 14
Hemorrhage/Bleeding 14 14
Paralysis 14 14
Therapeutic Response, Decreased 13 13
Blood Loss 13 13
Muscle/Tendon Damage 12 12
Skin Inflammation/ Irritation 12 12
Metal Related Pathology 11 11
Muscular Rigidity 11 11
Rash 9 9
Calcium Deposits/Calcification 9 9
Limited Mobility Of The Implanted Joint 9 9
Cyst(s) 8 8
Laceration(s) 8 8
Erythema 7 7
Cellulitis 7 7
Respiratory Failure 7 7
Numbness 7 7
Seroma 7 7
Spinal Column Injury 7 7
Unspecified Musculoskeletal problem 7 7
Localized Skin Lesion 6 6
Embolism/Embolus 6 6
Cardiopulmonary Arrest 6 6
Anemia 6 6
Fistula 6 6
Myocardial Infarction 5 5
Neuropathy 5 5
Adhesion(s) 5 5
Cardiac Arrest 5 5
Erosion 5 5
Rupture 5 5
Fibrosis 5 5
Cancer 5 5
Fluid Discharge 4 4
Ulcer 4 4
Pulmonary Edema 4 4
Swelling 4 4
Sedation 4 4
Fracture, Arm 4 4

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 Integra LifeSciences Corp. II Mar-23-2017
6 Merete Medical GmbH II Nov-06-2020
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 Ortho Solutions Inc II Jul-28-2017
12 OrthoPediatrics Corp II Oct-25-2019
13 OrthoPediatrics Corp II Oct-13-2019
14 Pega Medical Inc. II Aug-14-2019
15 Smith & Nephew, Inc. II Aug-22-2023
16 Stryker GmbH II Jul-30-2021
17 Stryker GmbH II Jun-16-2020
18 Stryker GmbH II Aug-22-2018
19 Stryker GmbH II Jul-10-2018
20 Synthes (USA) Products LLC II Mar-10-2023
21 Synthes (USA) Products LLC II Feb-13-2018
22 Wright Medical Technology, Inc. II Nov-25-2019
23 Wright Medical Technology, Inc. II Apr-13-2018
24 Zimmer Biomet, Inc. II Nov-07-2019
25 Zimmer Biomet, Inc. II Nov-14-2018
26 Zimmer Biomet, Inc. II Oct-18-2018
27 Zimmer Biomet, Inc. II Sep-25-2018
28 Zimmer Biomet, Inc. II Sep-13-2018
29 Zimmer Biomet, Inc. II Apr-25-2018
30 Zimmer Biomet, Inc. II Apr-20-2018
31 Zimmer Biomet, Inc. II Mar-27-2018
32 Zimmer Biomet, Inc. II Mar-14-2018
33 Zimmer Biomet, Inc. II Mar-14-2018
34 Zimmer Biomet, Inc. II Jan-29-2018
35 Zimmer Biomet, Inc. II Jun-15-2017
36 Zimmer Biomet, Inc. II Jun-01-2017
37 Zimmer Biomet, Inc. II Mar-20-2017
38 Zimmer GmbH II Jun-04-2021
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