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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
BIOMET INC.
  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 1
GLW, INC.
  SUBSTANTIALLY EQUIVALENT 2
GPC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRAUMA S.P.A.
  SUBSTANTIALLY EQUIVALENT 1
MERETE GMBH
  SUBSTANTIALLY EQUIVALENT 1
NEOORTHO PRODUTOS ORTOPÉDICOS S/A
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
  SUBSTANTIALLY EQUIVALENT 8
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOXEL
  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 4
STRYKER TRAUMA GMBH
  SUBSTANTIALLY EQUIVALENT 5
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES (USA) PRODUCTS, LLC
  SUBSTANTIALLY EQUIVALENT 1
THE ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
WITTENSTEIN INTENS GMBH
  SUBSTANTIALLY EQUIVALENT 1
X-BOLT ORTHOPAEDICS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 3525 3525
2019 2514 2514
2020 3300 3300
2021 4112 4112
2022 2738 2807

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 4928 4993
Break 3086 3086
Device-Device Incompatibility 1574 1574
Migration 1399 1403
Fracture 1063 1063
Appropriate Term/Code Not Available 549 549
Migration or Expulsion of Device 384 384
Insufficient Information 354 354
Packaging Problem 268 268
Device Contaminated During Manufacture or Shipping 267 267
Material Twisted/Bent 230 230
Material Deformation 223 223
Failure to Align 200 200
Delivered as Unsterile Product 193 193
Mechanical Problem 185 185
Device Operates Differently Than Expected 148 148
Mechanical Jam 138 138
Connection Problem 124 124
Patient Device Interaction Problem 120 120
Defective Device 97 97
Device Dislodged or Dislocated 91 91
Use of Device Problem 91 91
No Apparent Adverse Event 79 79
Material Discolored 78 78
Corroded 75 75
Unintended Movement 73 73
Crack 72 72
Detachment of Device or Device Component 67 67
Separation Problem 64 64
Malposition of Device 61 61
Naturally Worn 57 57
Loose or Intermittent Connection 52 52
Material Integrity Problem 47 47
Difficult to Remove 45 45
Positioning Failure 44 44
Loosening of Implant Not Related to Bone-Ingrowth 44 44
Difficult to Advance 41 41
Contamination /Decontamination Problem 38 38
Device Slipped 38 38
Physical Resistance/Sticking 36 36
Difficult to Insert 35 35
Entrapment of Device 33 33
Incomplete or Inadequate Connection 33 33
Material Fragmentation 31 31
Patient-Device Incompatibility 31 31
Improper or Incorrect Procedure or Method 30 30
Fitting Problem 29 29
Positioning Problem 28 28
Manufacturing, Packaging or Shipping Problem 27 27
Unstable 26 26
Failure to Osseointegrate 26 26
Inadequacy of Device Shape and/or Size 24 24
Material Protrusion/Extrusion 23 23
Activation, Positioning or Separation Problem 23 23
Unsealed Device Packaging 21 21
Deformation Due to Compressive Stress 20 20
Failure to Advance 20 20
Device Difficult to Setup or Prepare 18 18
Material Separation 18 18
Loss of or Failure to Bond 18 18
Dent in Material 17 17
Loss of Osseointegration 16 16
Separation Failure 16 16
No Device Output 16 16
Tear, Rip or Hole in Device Packaging 15 15
Defective Component 14 14
Device Difficult to Maintain 13 13
Difficult or Delayed Separation 13 13
Device Packaging Compromised 12 12
Component Missing 12 12
Disassembly 12 12
Bent 11 11
Device Damaged by Another Device 11 11
Device Markings/Labelling Problem 10 10
Osseointegration Problem 10 10
Collapse 10 10
Failure To Adhere Or Bond 9 9
Difficult or Delayed Positioning 9 9
Flaked 9 9
Therapeutic or Diagnostic Output Failure 9 9
Inaccurate Information 9 9
Device Handling Problem 8 8
Device Contamination with Chemical or Other Material 8 8
Device Damaged Prior to Use 8 8
Device Inoperable 7 7
Misassembled 7 7
Degraded 7 7
Protective Measures Problem 7 7
Failure to Disconnect 7 7
Installation-Related Problem 6 6
Mechanics Altered 6 6
Off-Label Use 6 6
Difficult To Position 5 5
Material Erosion 5 5
Human-Device Interface Problem 5 5
Device Disinfection Or Sterilization Issue 5 5
Expulsion 5 5
Dull, Blunt 5 5
Expiration Date Error 4 4
Compatibility Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2685 2685
No Code Available 2297 2297
Failure of Implant 1863 1863
Non-union Bone Fracture 1422 1478
Pain 1254 1255
Bone Fracture(s) 1221 1221
No Consequences Or Impact To Patient 1031 1031
No Patient Involvement 948 948
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 739 739
No Known Impact Or Consequence To Patient 728 728
Injury 585 585
Unspecified Infection 526 526
Insufficient Information 477 481
Limb Fracture 475 475
Post Operative Wound Infection 289 289
Death 257 257
Impaired Healing 237 238
No Information 230 230
Implant Pain 202 212
Hip Fracture 193 193
Malunion of Bone 151 151
Physical Asymmetry 150 150
Necrosis 142 142
Foreign Body In Patient 133 133
Unspecified Tissue Injury 110 110
Discomfort 92 92
Osteolysis 86 86
Ambulation Difficulties 73 73
Hematoma 72 72
Nerve Damage 63 64
Perforation 63 63
Device Embedded In Tissue or Plaque 56 56
Not Applicable 53 53
Loss of Range of Motion 51 57
Inflammation 50 50
Fall 49 49
Tissue Damage 49 49
Irritation 42 42
Ossification 36 36
Deformity/ Disfigurement 36 37
Arthritis 34 34
Hypersensitivity/Allergic reaction 32 32
Reaction 32 32
Joint Dislocation 28 28
Patient Problem/Medical Problem 25 25
Bacterial Infection 23 23
Wound Dehiscence 23 23
Osteopenia/ Osteoporosis 22 22
Pulmonary Embolism 21 21
Unequal Limb Length 21 21
Complaint, Ill-Defined 19 19
Swelling/ Edema 18 18
Thrombosis/Thrombus 18 18
Skin Irritation 17 17
Thrombosis 16 16
Inadequate Osseointegration 16 16
Fatigue 16 16
Sepsis 15 15
Hemorrhage/Bleeding 14 14
Abscess 14 14
Blood Loss 13 13
Therapeutic Response, Decreased 13 13
Joint Laxity 13 13
Osteomyelitis 12 12
Paralysis 12 12
Muscular Rigidity 10 10
Skin Inflammation/ Irritation 10 10
Metal Related Pathology 9 9
Calcium Deposits/Calcification 9 9
Cyst(s) 7 7
Spinal Column Injury 7 7
Numbness 7 7
Respiratory Failure 7 7
Limited Mobility Of The Implanted Joint 6 6
Seroma 6 6
Cardiopulmonary Arrest 6 6
Fistula 6 6
Erythema 6 6
Embolism/Embolus 6 6
Localized Skin Lesion 6 6
Unspecified Musculoskeletal problem 5 5
Muscle/Tendon Damage 5 5
Cellulitis 5 5
Anemia 5 5
Erosion 5 5
Neuropathy 5 5
Myocardial Infarction 5 5
Pulmonary Edema 4 4
Adhesion(s) 4 4
Abrasion 4 4
Edema 4 4
Foreign Body Reaction 4 4
Needle Stick/Puncture 4 4
Fracture, Arm 4 4
Fluid Discharge 4 4
Cancer Cells Dissemination 3 3
Arthralgia 3 3
Ulcer 3 3
Pressure Sores 3 3
Urinary 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 Jan-03-2022
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 OrthoPediatrics Corp II Oct-25-2019
10 OrthoPediatrics Corp II Oct-13-2019
11 Pega Medical Inc. II Aug-14-2019
12 Stryker GmbH II Jul-30-2021
13 Stryker GmbH II Jun-16-2020
14 Stryker GmbH II Aug-22-2018
15 Stryker GmbH II Jul-10-2018
16 Synthes (USA) Products LLC II Feb-13-2018
17 Wright Medical Technology, Inc. II Nov-25-2019
18 Wright Medical Technology, Inc. II Apr-13-2018
19 Zimmer Biomet, Inc. II Nov-07-2019
20 Zimmer Biomet, Inc. II Nov-14-2018
21 Zimmer Biomet, Inc. II Oct-18-2018
22 Zimmer Biomet, Inc. II Sep-25-2018
23 Zimmer Biomet, Inc. II Sep-13-2018
24 Zimmer Biomet, Inc. II Apr-25-2018
25 Zimmer Biomet, Inc. II Apr-20-2018
26 Zimmer Biomet, Inc. II Mar-27-2018
27 Zimmer Biomet, Inc. II Mar-14-2018
28 Zimmer Biomet, Inc. II Mar-14-2018
29 Zimmer Biomet, Inc. II Jan-29-2018
30 Zimmer GmbH II Jun-04-2021
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