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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
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
FLOW-FX, LLC
  SUBSTANTIALLY EQUIVALENT 1
FLOWER ORTHOPEDICS CORPORATION DBA CONVENTUS FLOWER
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 2
GLW, INC.
  SUBSTANTIALLY EQUIVALENT 1
GPC MEDICAL LIMITED
  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, 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 3
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 3300 3300
2021 4112 4112
2022 1973 2042

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5042 5107
Break 3278 3278
Device-Device Incompatibility 1512 1512
Migration 1296 1300
Fracture 1074 1074
Appropriate Term/Code Not Available 564 564
Migration or Expulsion of Device 474 474
Insufficient Information 412 412
Packaging Problem 269 269
Device Contaminated During Manufacture or Shipping 267 267
Device Operates Differently Than Expected 260 260
Failure to Align 235 235
Material Deformation 218 218
Material Twisted/Bent 218 218
Mechanical Problem 198 198
Delivered as Unsterile Product 193 193
Mechanical Jam 157 157
Unintended Movement 140 140
Connection Problem 125 125
Patient Device Interaction Problem 112 112
Defective Device 100 100
Use of Device Problem 96 96
Material Discolored 79 79
Device Dislodged or Dislocated 79 79
No Apparent Adverse Event 78 78
Corroded 75 75
Crack 75 75
Fitting Problem 66 66
Detachment of Device or Device Component 64 64
Separation Problem 64 64
Malposition of Device 62 62
Difficult to Remove 62 62
Loose or Intermittent Connection 57 57
Naturally Worn 57 57
Difficult to Insert 55 55
Material Integrity Problem 49 49
Device Slipped 41 41
Loosening of Implant Not Related to Bone-Ingrowth 41 41
Positioning Failure 40 40
Difficult to Advance 40 40
Contamination /Decontamination Problem 40 40
Improper or Incorrect Procedure or Method 38 38
Material Fragmentation 37 37
Physical Resistance/Sticking 36 36
Positioning Problem 34 34
Incomplete or Inadequate Connection 33 33
Entrapment of Device 32 32
Unsealed Device Packaging 32 32
Patient-Device Incompatibility 31 31
Manufacturing, Packaging or Shipping Problem 28 28
Inadequacy of Device Shape and/or Size 27 27
Failure to Osseointegrate 26 26
Unstable 25 25
Failure to Advance 25 25
Activation, Positioning or SeparationProblem 23 23
Material Protrusion/Extrusion 23 23
Component Missing 21 21
Tear, Rip or Hole in Device Packaging 21 21
Material Separation 21 21
Failure To Adhere Or Bond 21 21
Loss of or Failure to Bond 19 19
Deformation Due to Compressive Stress 19 19
Loss of Osseointegration 18 18
Bent 18 18
Detachment Of Device Component 18 18
Dent in Material 17 17
Device Packaging Compromised 16 16
No Device Output 16 16
Device Difficult to Setup or Prepare 14 14
Disassembly 14 14
Defective Component 14 14
Separation Failure 14 14
Device Markings/Labelling Problem 13 13
Device Damaged by Another Device 13 13
Device Contamination with Chemical or Other Material 13 13
Difficult or Delayed Separation 13 13
Device Difficult to Maintain 13 13
Activation Failure 11 11
Out-Of-Box Failure 11 11
Sticking 11 11
Inflation Problem 10 10
Collapse 10 10
Osseointegration Problem 10 10
Device Handling Problem 10 10
Therapeutic or Diagnostic Output Failure 9 9
Incomplete or Missing Packaging 9 9
Device Damaged Prior to Use 9 9
Failure to Disconnect 9 9
Difficult or Delayed Positioning 9 9
Flaked 9 9
Device Inoperable 9 9
Off-Label Use 9 9
Difficult To Position 9 9
Mechanics Altered 8 8
Protective Measures Problem 7 7
Misassembled 7 7
Degraded 7 7
Inaccurate Information 7 7
Installation-Related Problem 6 6
Device Operational Issue 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 2669 2669
No Clinical Signs, Symptoms or Conditions 2457 2457
Failure of Implant 1908 1908
Non-union Bone Fracture 1440 1496
Bone Fracture(s) 1414 1414
Pain 1391 1392
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 717 717
Injury 607 607
Unspecified Infection 556 556
Insufficient Information 445 449
Limb Fracture 387 387
No Information 329 329
Post Operative Wound Infection 280 280
Impaired Healing 269 270
Death 265 265
Hip Fracture 196 196
Implant Pain 190 200
Malunion of Bone 149 149
Necrosis 142 142
Physical Asymmetry 140 140
Foreign Body In Patient 138 138
Unspecified Tissue Injury 101 101
Osteolysis 88 88
Discomfort 86 86
Device Embedded In Tissue or Plaque 81 81
Ambulation Difficulties 72 72
Fall 67 67
Nerve Damage 62 63
Hematoma 62 62
Not Applicable 56 56
Loss of Range of Motion 55 61
Tissue Damage 50 50
Perforation 49 49
Inflammation 48 48
Irritation 46 46
Arthritis 43 43
Ossification 36 36
Deformity/ Disfigurement 34 35
Reaction 34 34
Hypersensitivity/Allergic reaction 32 32
Joint Dislocation 28 28
Patient Problem/Medical Problem 25 25
Bacterial Infection 25 25
Osteopenia/ Osteoporosis 23 23
Wound Dehiscence 21 21
Unequal Limb Length 21 21
Pulmonary Embolism 20 20
Complaint, Ill-Defined 19 19
Swelling/ Edema 18 18
Thrombosis/Thrombus 18 18
Skin Irritation 17 17
Fatigue 17 17
Thrombosis 16 16
Inadequate Osseointegration 14 14
Abscess 14 14
Blood Loss 13 13
Therapeutic Response, Decreased 13 13
Hemorrhage/Bleeding 12 12
Paralysis 12 12
Osteomyelitis 11 11
Muscular Rigidity 10 10
Rash 9 9
Calcium Deposits/Calcification 9 9
Limited Mobility Of The Implanted Joint 9 9
Spinal Column Injury 7 7
Erythema 7 7
Sepsis 7 7
Metal Related Pathology 7 7
Joint Laxity 7 7
Embolism/Embolus 6 6
Localized Skin Lesion 6 6
Skin Inflammation/ Irritation 6 6
Cyst(s) 6 6
Fistula 6 6
Cardiopulmonary Arrest 6 6
Cellulitis 6 6
Seroma 6 6
Numbness 6 6
Respiratory Failure 6 6
Adhesion(s) 5 5
Anemia 5 5
Erosion 5 5
Neuropathy 5 5
Myocardial Infarction 5 5
Muscle/Tendon Damage 5 5
Unspecified Musculoskeletal problem 4 4
Fibrosis 4 4
Pulmonary Edema 4 4
Abrasion 4 4
Edema 4 4
Needle Stick/Puncture 4 4
Fluid Discharge 4 4
Swelling 4 4
Rupture 4 4
Sedation 4 4
Fracture, Arm 4 4
Arthralgia 4 4

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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