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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
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
ELLIPSE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
ELLIPSE TECHNOLOGIES, INCORPORATED
  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
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 3
RENOVO LIFE LLC
  SUBSTANTIALLY EQUIVALENT 1
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
SONOMA ORTHOPEDICS 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 3
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
2016 1920 1920
2017 1447 1447
2018 3525 3525
2019 2514 2514
2020 3298 3298
2021 3127 3127

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4610 4610
Break 3030 3030
Device-Device Incompatibility 1164 1164
Migration 997 997
Fracture 942 942
Appropriate Term/Code Not Available 597 597
Insufficient Information 472 472
Migration or Expulsion of Device 412 412
Device Operates Differently Than Expected 398 398
Failure to Align 282 282
Packaging Problem 273 273
Device Contaminated During Manufacture or Shipping 266 266
Delivered as Unsterile Product 198 198
Unintended Movement 195 195
Material Deformation 180 180
Mechanical Jam 169 169
Material Twisted/Bent 163 163
Mechanical Problem 149 149
Connection Problem 123 123
Fitting Problem 122 122
Defective Device 94 94
Use of Device Problem 81 81
Material Discolored 79 79
Difficult to Remove 73 73
Difficult to Insert 70 70
Malposition of Device 70 70
Device Dislodged or Dislocated 67 67
Device Handling Problem 65 65
Separation Problem 64 64
No Apparent Adverse Event 63 63
Loose or Intermittent Connection 61 61
Corroded 58 58
Crack 54 54
Naturally Worn 50 50
Detachment of Device or Device Component 48 48
Material Fragmentation 46 46
Improper or Incorrect Procedure or Method 45 45
Positioning Problem 43 43
Device Slipped 41 41
Device Packaging Compromised 41 41
Material Protrusion/Extrusion 37 37
Patient-Device Incompatibility 37 37
Failure To Adhere Or Bond 36 36
Contamination /Decontamination Problem 35 35
Unsealed Device Packaging 34 34
Bent 33 33
Loosening of Implant Not Related to Bone-Ingrowth 33 33
Difficult to Advance 33 33
Incomplete or Inadequate Connection 33 33
Material Integrity Problem 32 32
Physical Resistance/Sticking 31 31
Inadequacy of Device Shape and/or Size 31 31
Sticking 28 28
Tear, Rip or Hole in Device Packaging 28 28
Entrapment of Device 27 27
Failure to Advance 27 27
Material Separation 26 26
Failure to Osseointegrate 26 26
Loss of or Failure to Bond 25 25
Component Missing 24 24
Detachment Of Device Component 24 24
Positioning Failure 21 21
Patient Device Interaction Problem 20 20
Device Contamination with Chemical or Other Material 20 20
Device Markings/Labelling Problem 18 18
Activation, Positioning or SeparationProblem 18 18
Dent in Material 17 17
Unstable 17 17
Loss of Osseointegration 16 16
Disassembly 16 16
Device Expiration Issue 15 15
Difficult To Position 15 15
Separation Failure 13 13
Manufacturing, Packaging or Shipping Problem 13 13
Device Difficult to Maintain 13 13
Activation Failure 12 12
Defective Component 12 12
Mechanics Altered 11 11
Out-Of-Box Failure 11 11
Device Damaged by Another Device 11 11
Collapse 11 11
Difficult or Delayed Separation 11 11
Inflation Problem 10 10
Device Inoperable 10 10
Component Falling 10 10
Failure to Disconnect 9 9
Incomplete or Missing Packaging 9 9
Therapeutic or Diagnostic Output Failure 9 9
Expiration Date Error 8 8
Off-Label Use 8 8
Device Operational Issue 8 8
Device Damaged Prior to Use 8 8
Dull, Blunt 7 7
Difficult or Delayed Positioning 7 7
Misassembled 7 7
Degraded 7 7
Protective Measures Problem 7 7
Noise, Audible 7 7
No Device Output 6 6
Material Erosion 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 3116 3116
Failure of Implant 1766 1766
Bone Fracture(s) 1661 1661
Pain 1376 1377
No Known Impact Or Consequence To Patient 1369 1369
No Clinical Signs, Symptoms or Conditions 1343 1343
Non-union Bone Fracture 1317 1317
No Consequences Or Impact To Patient 1123 1123
No Patient Involvement 998 998
Injury 632 632
Unspecified Infection 578 578
No Information 449 449
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 447 447
Impaired Healing 342 342
Death 275 275
Post Operative Wound Infection 231 231
Insufficient Information 189 189
Hip Fracture 177 177
Limb Fracture 168 168
Foreign Body In Patient 123 123
Necrosis 122 122
Device Embedded In Tissue or Plaque 106 106
Physical Asymmetry 101 101
Malunion of Bone 92 92
Implant Pain 86 86
Fall 85 85
Osteolysis 83 83
Unspecified Tissue Injury 83 83
Discomfort 83 83
Sedation 62 62
Ambulation Difficulties 61 61
Nerve Damage 60 60
Not Applicable 58 58
Irritation 57 57
Tissue Damage 54 54
Hematoma 53 53
Reaction 40 40
Perforation 39 39
Loss of Range of Motion 39 39
Inflammation 38 38
Arthritis 38 38
Ossification 35 35
Bacterial Infection 28 28
Hypersensitivity/Allergic reaction 28 28
Patient Problem/Medical Problem 25 25
Complaint, Ill-Defined 22 22
Osteopenia/ Osteoporosis 22 22
Joint Dislocation 21 21
Skin Irritation 18 18
Deformity/ Disfigurement 17 17
Thrombosis 16 16
Blood Loss 16 16
Unequal Limb Length 16 16
Swelling 15 15
Wound Dehiscence 15 15
Inadequate Osseointegration 13 13
Therapeutic Response, Decreased 13 13
Paralysis 12 12
Abscess 12 12
Pulmonary Embolism 11 11
Rash 11 11
Limited Mobility Of The Implanted Joint 11 11
Muscular Rigidity 9 9
Numbness 9 9
Calcium Deposits/Calcification 9 9
Erythema 9 9
Thrombosis/Thrombus 9 9
Swelling/ Edema 8 8
Osteomyelitis 7 7
Spinal Column Injury 7 7
Sepsis 7 7
Staphylococcus Aureus 6 6
Cardiopulmonary Arrest 6 6
Cyst(s) 6 6
Localized Skin Lesion 6 6
Seroma 6 6
Pneumonia 5 5
Myocardial Infarction 5 5
Cellulitis 5 5
Arthralgia 5 5
Erosion 5 5
Neuropathy 5 5
Collapse 5 5
Fracture, Arm 5 5
Respiratory Failure 5 5
Pressure Sores 4 4
Rupture 4 4
Oversedation 4 4
Abrasion 4 4
Anemia 4 4
Fluid Discharge 4 4
Muscle/Tendon Damage 4 4
Joint Swelling 4 4
Burning Sensation 4 4
Edema 4 4
Fistula 4 4
Itching Sensation 4 4
Pulmonary Edema 4 4
Fibrosis 4 4
Scar Tissue 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II Dec-17-2020
2 Biomet, Inc. II May-26-2016
3 CarboFix Orthopedics, Ltd. II Jun-14-2016
4 Integra LifeSciences Corp. II Mar-23-2017
5 Merete Medical GmbH II Nov-06-2020
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 OrthoPediatrics Corp III Dec-22-2016
13 Pega Medical Inc. II Aug-14-2019
14 Stryker GmbH II Jul-30-2021
15 Stryker GmbH II Jun-16-2020
16 Stryker GmbH II Aug-22-2018
17 Stryker GmbH II Jul-10-2018
18 Stryker Howmedica Osteonics Corp. II Sep-13-2016
19 Stryker Howmedica Osteonics Corp. II Feb-25-2016
20 Synthes (USA) Products LLC II Feb-13-2018
21 Synthes (USA) Products LLC II Nov-19-2016
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
39 Zimmer Manufacturing B.V. II May-16-2016
40 Zimmer Manufacturing B.V. II Mar-12-2016
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