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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 2
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. (AOS)
  SUBSTANTIALLY EQUIVALENT 1
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAAT MEDICAL PRODUCTS BV
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS 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
FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
GLW, INC.
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  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
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 14
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 3
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
SONOMA ORTHOPEDIC PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER GMBH
  SUBSTANTIALLY EQUIVALENT 2
STRYKER TRAUMA GMBH
  SUBSTANTIALLY EQUIVALENT 5
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 2
THE ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
WITTENSTEIN INTENS GMBH
  SUBSTANTIALLY EQUIVALENT 2
X-BOLT ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1447 1447
2018 3525 3525
2019 2514 2514
2020 3299 3299
2021 4093 4093

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4377 4377
Break 2843 2843
Device-Device Incompatibility 1292 1292
Migration 1096 1096
Fracture 896 896
Appropriate Term/Code Not Available 561 561
Insufficient Information 406 406
Migration or Expulsion of Device 384 384
Packaging Problem 269 269
Device Contaminated During Manufacture or Shipping 266 266
Device Operates Differently Than Expected 260 260
Failure to Align 216 216
Delivered as Unsterile Product 193 193
Material Deformation 186 186
Material Twisted/Bent 180 180
Mechanical Problem 166 166
Mechanical Jam 143 143
Unintended Movement 138 138
Connection Problem 125 125
Defective Device 96 96
Use of Device Problem 83 83
Material Discolored 78 78
Corroded 70 70
No Apparent Adverse Event 67 67
Fitting Problem 65 65
Device Dislodged or Dislocated 64 64
Separation Problem 64 64
Crack 61 61
Malposition of Device 58 58
Loose or Intermittent Connection 56 56
Difficult to Remove 53 53
Detachment of Device or Device Component 51 51
Difficult to Insert 49 49
Naturally Worn 48 48
Patient Device Interaction Problem 43 43
Loosening of Implant Not Related to Bone-Ingrowth 40 40
Material Integrity Problem 39 39
Improper or Incorrect Procedure or Method 37 37
Contamination /Decontamination Problem 35 35
Incomplete or Inadequate Connection 33 33
Difficult to Advance 32 32
Positioning Problem 32 32
Unsealed Device Packaging 32 32
Material Fragmentation 31 31
Patient-Device Incompatibility 31 31
Physical Resistance/Sticking 31 31
Device Slipped 30 30
Entrapment of Device 29 29
Inadequacy of Device Shape and/or Size 26 26
Failure to Osseointegrate 26 26
Failure to Advance 24 24
Material Protrusion/Extrusion 23 23
Unstable 23 23
Positioning Failure 23 23
Failure To Adhere Or Bond 21 21
Component Missing 21 21
Tear, Rip or Hole in Device Packaging 21 21
Material Separation 20 20
Loss of or Failure to Bond 19 19
Bent 18 18
Detachment Of Device Component 18 18
Activation, Positioning or SeparationProblem 18 18
Manufacturing, Packaging or Shipping Problem 18 18
Loss of Osseointegration 17 17
Dent in Material 16 16
Device Packaging Compromised 16 16
Disassembly 14 14
Separation Failure 13 13
Device Contamination with Chemical or Other Material 13 13
Device Difficult to Maintain 13 13
Defective Component 12 12
Device Markings/Labelling Problem 12 12
Device Damaged by Another Device 11 11
Out-Of-Box Failure 11 11
Sticking 11 11
Difficult or Delayed Separation 11 11
Activation Failure 11 11
No Device Output 10 10
Inflation Problem 10 10
Device Handling Problem 10 10
Osseointegration Problem 10 10
Therapeutic or Diagnostic Output Failure 9 9
Incomplete or Missing Packaging 9 9
Failure to Disconnect 9 9
Difficult To Position 9 9
Device Inoperable 9 9
Device Damaged Prior to Use 9 9
Collapse 8 8
Mechanics Altered 8 8
Protective Measures Problem 7 7
Degraded 7 7
Difficult or Delayed Positioning 7 7
Device Difficult to Setup or Prepare 7 7
Off-Label Use 7 7
Misassembled 7 7
Dull, Blunt 6 6
Device Operational Issue 6 6
Deformation Due to Compressive Stress 6 6
Device Disinfection Or Sterilization Issue 5 5
Expiration Date Error 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2669 2669
No Clinical Signs, Symptoms or Conditions 1744 1744
Failure of Implant 1649 1649
Bone Fracture(s) 1310 1310
Pain 1258 1259
Non-union Bone Fracture 1228 1228
No Consequences Or Impact To Patient 1087 1087
No Known Impact Or Consequence To Patient 1021 1021
No Patient Involvement 973 973
Injury 607 607
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 540 540
Unspecified Infection 515 515
No Information 329 329
Insufficient Information 275 275
Death 265 265
Impaired Healing 252 252
Limb Fracture 247 247
Post Operative Wound Infection 245 245
Hip Fracture 184 184
Necrosis 123 123
Malunion of Bone 119 119
Implant Pain 113 113
Physical Asymmetry 113 113
Foreign Body In Patient 113 113
Unspecified Tissue Injury 90 90
Osteolysis 88 88
Device Embedded In Tissue or Plaque 79 79
Discomfort 73 73
Fall 63 63
Nerve Damage 56 56
Not Applicable 56 56
Ambulation Difficulties 55 55
Hematoma 55 55
Tissue Damage 50 50
Irritation 46 46
Loss of Range of Motion 38 38
Arthritis 38 38
Inflammation 34 34
Reaction 34 34
Perforation 33 33
Ossification 27 27
Hypersensitivity/Allergic reaction 25 25
Patient Problem/Medical Problem 25 25
Bacterial Infection 24 24
Osteopenia/ Osteoporosis 22 22
Joint Dislocation 19 19
Complaint, Ill-Defined 19 19
Deformity/ Disfigurement 19 19
Wound Dehiscence 18 18
Unequal Limb Length 18 18
Skin Irritation 17 17
Thrombosis 16 16
Abscess 14 14
Therapeutic Response, Decreased 13 13
Inadequate Osseointegration 13 13
Blood Loss 13 13
Pulmonary Embolism 11 11
Paralysis 11 11
Osteomyelitis 11 11
Thrombosis/Thrombus 10 10
Swelling/ Edema 9 9
Rash 9 9
Muscular Rigidity 9 9
Calcium Deposits/Calcification 9 9
Limited Mobility Of The Implanted Joint 9 9
Spinal Column Injury 7 7
Sepsis 7 7
Erythema 7 7
Joint Laxity 7 7
Localized Skin Lesion 6 6
Fistula 6 6
Cardiopulmonary Arrest 6 6
Cellulitis 6 6
Cyst(s) 6 6
Seroma 6 6
Numbness 6 6
Respiratory Failure 5 5
Neuropathy 5 5
Myocardial Infarction 5 5
Erosion 5 5
Abrasion 4 4
Anemia 4 4
Edema 4 4
Hemorrhage/Bleeding 4 4
Pulmonary Edema 4 4
Fluid Discharge 4 4
Fibrosis 4 4
Swelling 4 4
Rupture 4 4
Sedation 4 4
Fracture, Arm 4 4
Muscle/Tendon Damage 4 4
Embolism/Embolus 3 3
Skin Inflammation/ Irritation 3 3
Cancer Cells Dissemination 3 3
Arthralgia 3 3
Burning Sensation 3 3
Tingling 3 3
Pressure Sores 3 3
Post Traumatic Wound Infection 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Flower Orthopedics Corporation II Jan-03-2022
3 Integra LifeSciences Corp. II Mar-23-2017
4 Merete Medical GmbH II Nov-06-2020
5 NuVasive Specialized Orthopedics, Inc. II Dec-01-2021
6 Nuvasive Specialized Orthopedics Inc II Apr-05-2021
7 Nuvasive Specialized Orthopedics Inc II Mar-30-2021
8 Nuvasive Specialized Orthopedics Inc II Oct-07-2020
9 Ortho Solutions Inc II Jul-28-2017
10 OrthoPediatrics Corp II Oct-25-2019
11 OrthoPediatrics Corp II Oct-13-2019
12 Pega Medical Inc. II Aug-14-2019
13 Stryker GmbH II Jul-30-2021
14 Stryker GmbH II Jun-16-2020
15 Stryker GmbH II Aug-22-2018
16 Stryker GmbH II Jul-10-2018
17 Synthes (USA) Products LLC II Feb-13-2018
18 Wright Medical Technology, Inc. II Nov-25-2019
19 Wright Medical Technology, Inc. II Apr-13-2018
20 Zimmer Biomet, Inc. II Nov-07-2019
21 Zimmer Biomet, Inc. II Nov-14-2018
22 Zimmer Biomet, Inc. II Oct-18-2018
23 Zimmer Biomet, Inc. II Sep-25-2018
24 Zimmer Biomet, Inc. II Sep-13-2018
25 Zimmer Biomet, Inc. II Apr-25-2018
26 Zimmer Biomet, Inc. II Apr-20-2018
27 Zimmer Biomet, Inc. II Mar-27-2018
28 Zimmer Biomet, Inc. II Mar-14-2018
29 Zimmer Biomet, Inc. II Mar-14-2018
30 Zimmer Biomet, Inc. II Jan-29-2018
31 Zimmer Biomet, Inc. II Jun-15-2017
32 Zimmer Biomet, Inc. II Jun-01-2017
33 Zimmer Biomet, Inc. II Mar-20-2017
34 Zimmer GmbH II Jun-04-2021
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