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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 2
BAAT MEDICAL PRODUCTS BV
  SUBSTANTIALLY EQUIVALENT 1
BIOMET INC.
  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 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
INNOSYS
  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 10
ORTHO DEVELOPMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
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 5
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
X-BOLT ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER SWITZERLAND MANUFACTURING GMBH
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 3526 3526
2019 2516 2516
2020 3299 3299
2021 4111 4111
2022 2726 2795
2023 1520 1520

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5317 5382
Break 3482 3482
Device-Device Incompatibility 1815 1815
Migration 1628 1632
Fracture 1236 1236
Appropriate Term/Code Not Available 554 554
Migration or Expulsion of Device 394 394
Insufficient Information 360 360
Packaging Problem 270 270
Device Contaminated During Manufacture or Shipping 269 269
Material Twisted/Bent 257 257
Material Deformation 240 240
Failure to Align 216 216
Mechanical Problem 196 196
Delivered as Unsterile Product 194 194
Device Operates Differently Than Expected 148 148
Mechanical Jam 147 147
Patient Device Interaction Problem 132 132
Connection Problem 124 124
Use of Device Problem 108 108
Defective Device 103 103
Device Dislodged or Dislocated 95 95
No Apparent Adverse Event 91 91
Malposition of Device 85 85
Material Discolored 78 78
Corroded 76 76
Detachment of Device or Device Component 75 75
Unintended Movement 75 75
Crack 73 73
Separation Problem 64 64
Material Integrity Problem 59 59
Naturally Worn 57 57
Difficult to Advance 55 55
Positioning Failure 53 53
Loose or Intermittent Connection 52 52
Difficult to Remove 50 50
Device Slipped 47 47
Loosening of Implant Not Related to Bone-Ingrowth 43 43
Contamination /Decontamination Problem 42 42
Material Fragmentation 39 39
Difficult to Insert 37 37
Failure to Advance 37 37
Physical Resistance/Sticking 37 37
Entrapment of Device 36 36
Improper or Incorrect Procedure or Method 33 33
Incomplete or Inadequate Connection 33 33
Patient-Device Incompatibility 31 31
Manufacturing, Packaging or Shipping Problem 30 30
Fitting Problem 29 29
Positioning Problem 28 28
Failure to Osseointegrate 26 26
Unstable 26 26
Activation, Positioning or Separation Problem 25 25
Inadequacy of Device Shape and/or Size 24 24
Material Protrusion/Extrusion 23 23
Unsealed Device Packaging 22 22
Device Difficult to Setup or Prepare 21 21
Deformation Due to Compressive Stress 20 20
Tear, Rip or Hole in Device Packaging 19 19
Material Separation 18 18
Loss of or Failure to Bond 18 18
Dent in Material 17 17
Loss of Osseointegration 17 17
Separation Failure 17 17
No Device Output 16 16
Defective Component 14 14
Device Difficult to Maintain 14 14
Difficult or Delayed Separation 13 13
Device Packaging Compromised 12 12
Component Missing 12 12
Disassembly 12 12
Bent 11 11
Osseointegration Problem 11 11
Device Damaged by Another Device 11 11
Device Markings/Labelling Problem 10 10
Collapse 10 10
Failure To Adhere Or Bond 9 9
Degraded 9 9
Difficult or Delayed Positioning 9 9
Flaked 9 9
Device Handling Problem 9 9
Therapeutic or Diagnostic Output Failure 9 9
Mechanics Altered 9 9
Inaccurate Information 9 9
Device Contamination with Chemical or Other Material 8 8
Device Damaged Prior to Use 8 8
Failure to Disconnect 7 7
Protective Measures Problem 7 7
Device Inoperable 7 7
Off-Label Use 7 7
Misassembled 7 7
Unintended System Motion 6 6
Misassembly by Users 6 6
Installation-Related Problem 6 6
Human-Device Interface Problem 5 5
Expulsion 5 5
Output Problem 5 5
Dull, Blunt 5 5
Device Disinfection Or Sterilization Issue 5 5
Peeled/Delaminated 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3227 3227
No Code Available 2297 2297
Failure of Implant 2240 2240
Non-union Bone Fracture 1604 1660
Pain 1373 1374
Bone Fracture(s) 1261 1261
No Consequences Or Impact To Patient 1031 1031
No Patient Involvement 948 948
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 757 757
No Known Impact Or Consequence To Patient 728 728
Limb Fracture 637 637
Injury 585 585
Unspecified Infection 585 585
Insufficient Information 557 561
Post Operative Wound Infection 321 321
Death 257 257
Impaired Healing 246 247
Implant Pain 237 247
No Information 230 230
Hip Fracture 199 199
Malunion of Bone 165 165
Foreign Body In Patient 155 155
Physical Asymmetry 154 154
Necrosis 153 153
Unspecified Tissue Injury 128 128
Discomfort 95 95
Osteolysis 92 92
Ambulation Difficulties 91 91
Hematoma 73 73
Perforation 71 71
Fall 67 67
Nerve Damage 65 66
Loss of Range of Motion 61 67
Device Embedded In Tissue or Plaque 60 60
Inflammation 57 57
Not Applicable 53 53
Tissue Damage 49 49
Irritation 42 42
Deformity/ Disfigurement 40 41
Ossification 39 39
Arthritis 36 36
Swelling/ Edema 34 34
Hypersensitivity/Allergic reaction 32 32
Reaction 32 32
Joint Dislocation 29 29
Osteopenia/ Osteoporosis 26 26
Patient Problem/Medical Problem 25 25
Wound Dehiscence 25 25
Bacterial Infection 24 24
Pulmonary Embolism 21 21
Unequal Limb Length 21 21
Thrombosis/Thrombus 20 20
Complaint, Ill-Defined 19 19
Inadequate Osseointegration 18 18
Skin Irritation 17 17
Thrombosis 16 16
Abscess 16 16
Fatigue 16 16
Sepsis 15 15
Hemorrhage/Bleeding 14 14
Paralysis 14 14
Osteomyelitis 14 14
Joint Laxity 13 13
Therapeutic Response, Decreased 13 13
Blood Loss 13 13
Muscle/Tendon Damage 12 12
Skin Inflammation/ Irritation 12 12
Metal Related Pathology 11 11
Muscular Rigidity 11 11
Calcium Deposits/Calcification 9 9
Cyst(s) 8 8
Laceration(s) 8 8
Respiratory Failure 7 7
Numbness 7 7
Seroma 7 7
Spinal Column Injury 7 7
Unspecified Musculoskeletal problem 7 7
Localized Skin Lesion 6 6
Embolism/Embolus 6 6
Limited Mobility Of The Implanted Joint 6 6
Fistula 6 6
Erythema 6 6
Anemia 6 6
Cardiopulmonary Arrest 6 6
Cellulitis 6 6
Erosion 5 5
Myocardial Infarction 5 5
Neuropathy 5 5
Pulmonary Edema 4 4
Foreign Body Reaction 4 4
Adhesion(s) 4 4
Abrasion 4 4
Edema 4 4
Fluid Discharge 4 4
Needle Stick/Puncture 4 4
Ulcer 4 4
Fracture, Arm 4 4
Fibrosis 4 4
Cancer Cells Dissemination 3 3
Arthralgia 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 Smith & Nephew, Inc. II Aug-22-2023
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 Mar-10-2023
18 Synthes (USA) Products LLC II Feb-13-2018
19 Wright Medical Technology, Inc. II Nov-25-2019
20 Wright Medical Technology, Inc. II Apr-13-2018
21 Zimmer Biomet, Inc. II Nov-07-2019
22 Zimmer Biomet, Inc. II Nov-14-2018
23 Zimmer Biomet, Inc. II Oct-18-2018
24 Zimmer Biomet, Inc. II Sep-25-2018
25 Zimmer Biomet, Inc. II Sep-13-2018
26 Zimmer Biomet, Inc. II Apr-25-2018
27 Zimmer Biomet, Inc. II Apr-20-2018
28 Zimmer Biomet, Inc. II Mar-27-2018
29 Zimmer Biomet, Inc. II Mar-14-2018
30 Zimmer Biomet, Inc. II Mar-14-2018
31 Zimmer Biomet, Inc. II Jan-29-2018
32 Zimmer GmbH II Jun-04-2021
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