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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
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 1
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 4
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
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 2516 2516
2020 3299 3299
2021 4111 4111
2022 2726 2795
2023 2232 2232
2024 537 537

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4923 4988
Break 3299 3299
Device-Device Incompatibility 1900 1900
Migration 1706 1710
Fracture 1179 1179
Migration or Expulsion of Device 328 328
Material Twisted/Bent 284 284
Material Deformation 247 247
Failure to Align 184 184
Mechanical Problem 176 176
Appropriate Term/Code Not Available 164 164
Patient Device Interaction Problem 133 133
Mechanical Jam 121 121
Connection Problem 119 119
Defective Device 109 109
Use of Device Problem 106 106
No Apparent Adverse Event 97 97
Device Dislodged or Dislocated 90 90
Detachment of Device or Device Component 89 89
Insufficient Information 86 86
Corroded 83 83
Malposition of Device 76 76
Crack 72 72
Separation Problem 71 71
Packaging Problem 68 68
Material Integrity Problem 57 57
Positioning Failure 55 55
Difficult to Advance 53 53
Naturally Worn 52 52
Failure to Advance 51 51
Loosening of Implant Not Related to Bone-Ingrowth 47 47
Loose or Intermittent Connection 46 46
Device Slipped 43 43
Physical Resistance/Sticking 40 40
Material Fragmentation 37 37
Entrapment of Device 36 36
Difficult to Remove 36 36
Incomplete or Inadequate Connection 33 33
Improper or Incorrect Procedure or Method 31 31
Material Discolored 29 29
Difficult to Insert 29 29
Manufacturing, Packaging or Shipping Problem 29 29
Device Difficult to Setup or Prepare 28 28
Delivered as Unsterile Product 27 27
Unintended Movement 26 26
Fitting Problem 25 25
Unstable 22 22
Material Protrusion/Extrusion 22 22
Activation, Positioning or Separation Problem 22 22
Deformation Due to Compressive Stress 21 21
Separation Failure 20 20
Contamination /Decontamination Problem 19 19
Inadequacy of Device Shape and/or Size 18 18
Material Separation 18 18
Loss of Osseointegration 17 17
Positioning Problem 17 17
No Device Output 16 16
Defective Component 14 14
Device Damaged by Another Device 13 13
Patient-Device Incompatibility 13 13
Difficult or Delayed Separation 13 13
Tear, Rip or Hole in Device Packaging 12 12
Device Contaminated During Manufacture or Shipping 11 11
Osseointegration Problem 10 10
Device Difficult to Maintain 10 10
Off-Label Use 10 10
Degraded 10 10
Difficult or Delayed Positioning 9 9
Component Missing 9 9
Inaccurate Information 9 9
Therapeutic or Diagnostic Output Failure 9 9
Device Handling Problem 8 8
Output Problem 7 7
Device Markings/Labelling Problem 7 7
Device Damaged Prior to Use 7 7
Failure to Disconnect 7 7
Unsealed Device Packaging 7 7
Collapse 7 7
Flaked 7 7
Unintended System Motion 6 6
Failure to Osseointegrate 6 6
Human-Device Interface Problem 6 6
Mechanics Altered 5 5
Expulsion 5 5
Component Misassembled 5 5
Peeled/Delaminated 5 5
Product Quality Problem 5 5
Residue After Decontamination 5 5
Disconnection 5 5
Material Erosion 4 4
Dull, Blunt 4 4
Shipping Damage or Problem 4 4
Material Split, Cut or Torn 4 4
Activation Problem 4 4
Device Fell 4 4
Misassembly by Users 4 4
Misassembled During Installation 4 4
Installation-Related Problem 4 4
Scratched Material 3 3
Noise, Audible 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3632 3632
Failure of Implant 2189 2189
No Code Available 1565 1565
Non-union Bone Fracture 1498 1554
Pain 1099 1100
Bone Fracture(s) 977 977
No Consequences Or Impact To Patient 833 833
Insufficient Information 804 808
Limb Fracture 794 794
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 761 761
Injury 528 528
Unspecified Infection 466 466
No Known Impact Or Consequence To Patient 406 406
Post Operative Wound Infection 321 321
No Patient Involvement 283 283
Implant Pain 262 272
Impaired Healing 177 178
Foreign Body In Patient 175 175
Malunion of Bone 173 173
Hip Fracture 171 171
Physical Asymmetry 160 160
Necrosis 151 151
Unspecified Tissue Injury 139 139
Osteolysis 98 98
No Information 97 97
Ambulation Difficulties 95 95
Perforation 88 88
Fall 81 81
Discomfort 78 78
Hematoma 70 70
Loss of Range of Motion 60 66
Inflammation 58 58
Nerve Damage 50 51
Deformity/ Disfigurement 45 46
Device Embedded In Tissue or Plaque 43 43
Swelling/ Edema 39 39
Ossification 35 35
Arthritis 31 31
Hypersensitivity/Allergic reaction 31 31
Joint Dislocation 29 29
Osteopenia/ Osteoporosis 27 27
Reaction 26 26
Wound Dehiscence 24 24
Thrombosis/Thrombus 24 24
Unequal Limb Length 23 23
Joint Laxity 22 22
Abscess 20 20
Death 20 20
Pulmonary Embolism 18 18
Bacterial Infection 18 18
Irritation 18 18
Not Applicable 18 18
Patient Problem/Medical Problem 18 18
Fatigue 16 16
Osteomyelitis 16 16
Tissue Damage 15 15
Hemorrhage/Bleeding 14 14
Therapeutic Response, Decreased 13 13
Skin Inflammation/ Irritation 13 13
Metal Related Pathology 12 12
Muscle/Tendon Damage 12 12
Paralysis 12 12
Sepsis 12 12
Muscular Rigidity 11 11
Cyst(s) 11 11
Skin Irritation 11 11
Blood Loss 11 11
Thrombosis 10 10
Calcium Deposits/Calcification 9 9
Laceration(s) 8 8
Inadequate Osseointegration 8 8
Respiratory Failure 7 7
Seroma 7 7
Unspecified Musculoskeletal problem 7 7
Localized Skin Lesion 6 6
Complaint, Ill-Defined 6 6
Numbness 6 6
Cancer 6 6
Embolism/Embolus 6 6
Fistula 6 6
Erythema 6 6
Stroke/CVA 5 5
Cardiopulmonary Arrest 5 5
Erosion 5 5
Cellulitis 4 4
Abrasion 4 4
Adhesion(s) 4 4
Cardiac Arrest 4 4
Myocardial Infarction 4 4
Pulmonary Edema 4 4
Neuropathy 4 4
Fibrosis 4 4
Needle Stick/Puncture 4 4
Thromboembolism 4 4
Fracture, Arm 4 4
Perforation of Vessels 4 4
Urinary Tract Infection 3 3
Spinal Column Injury 3 3
Ulcer 3 3
Respiratory Tract Infection 3 3

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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