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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
ACCUMED SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED ORTHOPAEDIC SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 3
ADVANCED ORTHOPAEDIC SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ARTHREX, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOMET
  SUBSTANTIALLY EQUIVALENT 2
BIOMET INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOPRO, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARBOFIX ORTHOPEDICS LTD.
  SUBSTANTIALLY EQUIVALENT 3
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH 200, LLC
  SUBSTANTIALLY EQUIVALENT 1
CITIEFFE S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
DOUBLE MEDICAL TECHNOLOGY INC.
  SUBSTANTIALLY EQUIVALENT 1
ELLIPSE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
FH ORTHOPEDICS
  SUBSTANTIALLY EQUIVALENT 1
FOURNITURES HOSPITALIERES
  SUBSTANTIALLY EQUIVALENT 2
FOURNITURES HOSPITALIERES INDUSTRIE
  SUBSTANTIALLY EQUIVALENT 2
GLOBUS
  SUBSTANTIALLY EQUIVALENT 1
IN2BONES SAS
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA
  SUBSTANTIALLY EQUIVALENT 1
INTEGRA LIFESCIENCES CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRAFUSE LLC
  SUBSTANTIALLY EQUIVALENT 2
MEDSHAPE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
MERETE MEDICAL GMBH
  SUBSTANTIALLY EQUIVALENT 2
ORTHOFIX
  SUBSTANTIALLY EQUIVALENT 3
ORTHOFIX SRL
  SUBSTANTIALLY EQUIVALENT 3
ORTHOPAEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIATRICS, CORP
  SUBSTANTIALLY EQUIVALENT 1
ORTHOPEDIC DESIGNS NORTH AMERICA, INC.
  SUBSTANTIALLY EQUIVALENT 2
PEGA MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 3
RENOVO LIFE LLC
  SUBSTANTIALLY EQUIVALENT 1
SIGN FRACTURE CARE INTERNATIONAL
  SUBSTANTIALLY EQUIVALENT 2
SMITH & NEPHEW
  SUBSTANTIALLY EQUIVALENT 1
SMITH & NEPHEW, INC.
  SUBSTANTIALLY EQUIVALENT 2
SONOMA ORTHOPEDIC PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 6
SYNTEC SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
SYNTHES (USA) PRODUCTS LLC / MEDICAL DEVICE BUSINESS SERVICE
  SUBSTANTIALLY EQUIVALENT 3
THE ORTHOPEDIC IMPLANT COMPANY
  SUBSTANTIALLY EQUIVALENT 1
TRUEMED GROUP LLC
  SUBSTANTIALLY EQUIVALENT 1
WITTENSTEIN INTENS GMBH
  SUBSTANTIALLY EQUIVALENT 1
WRIGHT MEDICAL TECHNOLOGY, INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER BIOMET
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER GMBH
  SUBSTANTIALLY EQUIVALENT 3
ZIMMER INC.
  SUBSTANTIALLY EQUIVALENT 1
ZIMMER, INC.
  SUBSTANTIALLY EQUIVALENT 6

MDR Year MDR Reports MDR Events
2015 1671 1671
2016 1919 1919
2017 1447 1447
2018 3525 3525
2019 2512 2512
2020 2196 2196

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3168 3168
Break 2807 2807
Fracture 849 849
Device-Device Incompatibility 818 818
Appropriate Term/Code Not Available 594 594
Device Operates Differently Than Expected 559 559
Insufficient Information 524 524
Migration or Expulsion of Device 450 450
Migration 449 449
Screw 416 416
Failure to Align 299 299
Packaging Problem 275 275
Device Contaminated During Manufacture or Shipping 266 266
Unintended Movement 228 228
Delivered as Unsterile Product 198 198
Fitting Problem 177 177
Mechanical Jam 170 170
Mechanical Problem 107 107
Difficult to Remove 103 103
Difficult to Insert 88 88
Material Twisted/Bent 80 80
Defective Device 78 78
Device Packaging Compromised 74 74
Material Deformation 74 74
Failure To Adhere Or Bond 68 68
Malposition of Device 66 66
Device Dislodged or Dislocated 66 66
Device Handling Problem 64 64
Use of Device Problem 63 63
Sticking 56 56
Material Discolored 56 56
Improper or Incorrect Procedure or Method 55 55
Bent 55 55
No Apparent Adverse Event 53 53
Loose or Intermittent Connection 53 53
Positioning Problem 53 53
Device Slipped 50 50
Detachment of Device or Device Component 45 45
Material Fragmentation 43 43
Inadequacy of Device Shape and/or Size 43 43
Material Protrusion/Extrusion 39 39
Failure to Advance 37 37
Separation Problem 36 36
Crack 36 36
Contamination /Decontamination Problem 35 35
Connection Problem 34 34
Detachment Of Device Component 34 34
Difficult to Advance 33 33
Patient-Device Incompatibility 33 33
Tip 31 31
Unsealed Device Packaging 31 31
Loss of or Failure to Bond 30 30
Material Integrity Problem 30 30
Failure to Osseointegrate 29 29
Device Contamination with Chemical or Other Material 28 28
Nonstandard Device 27 27
Device Expiration Issue 26 26
Component Missing 25 25
Tear, Rip or Hole in Device Packaging 25 25
Unstable 23 23
Entrapment of Device 23 23
Material Separation 23 23
Rod 22 22
Device Markings/Labelling Problem 21 21
Difficult To Position 21 21
Mechanics Altered 20 20
Activation, Positioning or SeparationProblem 18 18
Positioning Failure 17 17
Dent in Material 17 17
Loss of Osseointegration 17 17
Disassembly 16 16
Device Inoperable 14 14
Defective Component 13 13
Device Difficult to Maintain 13 13
Activation Failure 12 12
Component Falling 12 12
Device Damaged by Another Device 12 12
Naturally Worn 11 11
Bolt 11 11
Out-Of-Box Failure 11 11
Collapse 10 10
Inflation Problem 10 10
Noise, Audible 10 10
Physical Resistance/Sticking 10 10
Lock 9 9
Pin 9 9
Knife 9 9
Incomplete or Missing Packaging 9 9
Shelf Life Exceeded 9 9
Off-Label Use 9 9
Separation Failure 8 8
Cap 8 8
Ring 8 8
Loosening of Implant Not Related to Bone-Ingrowth 8 8
Component or Accessory Incompatibility 8 8
Device Operational Issue 8 8
Corroded 8 8
Misassembled 8 8
Device Damaged Prior to Use 8 8
Failure to Disconnect 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 3321 3321
No Known Impact Or Consequence To Patient 1792 1792
Bone Fracture(s) 1602 1602
Failure of Implant 1470 1470
Pain 1331 1332
No Consequences Or Impact To Patient 1105 1105
Non-union Bone Fracture 1028 1028
No Patient Involvement 971 971
Injury 620 620
Unspecified Infection 550 550
No Information 503 503
Impaired Healing 371 371
Death 284 284
Sedation 173 173
Device Embedded In Tissue or Plaque 128 128
Post Operative Wound Infection 106 106
Fall 100 100
Foreign Body In Patient 96 96
Necrosis 88 88
Discomfort 81 81
Irritation 60 60
Not Applicable 58 58
Tissue Damage 56 56
Hip Fracture 54 54
Nerve Damage 39 39
Ambulation Difficulties 36 36
Arthritis 33 33
Reaction 32 32
Ossification 27 27
Perforation 25 25
Loss of Range of Motion 25 25
Osteolysis 25 25
Patient Problem/Medical Problem 23 23
Hematoma 22 22
Blood Loss 21 21
Inadequate Osseointegration 19 19
Bacterial Infection 19 19
No Clinical Signs, Symptoms or Conditions 19 19
Limited Mobility Of The Implanted Joint 18 18
Complaint, Ill-Defined 17 17
Inflammation 17 17
Thrombosis 16 16
Swelling 16 16
Joint Dislocation 14 14
Rash 14 14
Osteopenia/ Osteoporosis 12 12
Therapeutic Response, Decreased 12 12
Paralysis 12 12
Numbness 11 11
Deformity/ Disfigurement 10 10
Skin Irritation 10 10
Implant Pain 10 10
Hypersensitivity/Allergic reaction 8 8
Staphylococcus Aureus 7 7
Sepsis 7 7
Wound Dehiscence 7 7
Abscess 7 7
Spinal Column Injury 7 7
Arthralgia 7 7
Fracture, Arm 6 6
Pulmonary Embolism 6 6
Calcium Deposits/Calcification 6 6
Cardiopulmonary Arrest 6 6
Cyst(s) 6 6
Erythema 6 6
Muscle Weakness 5 5
Erosion 5 5
Anemia 5 5
Rupture 5 5
Collapse 5 5
Pneumonia 5 5
Burning Sensation 5 5
Hemorrhage/Bleeding 5 5
Cellulitis 5 5
Cardiac Arrest 4 4
Itching Sensation 4 4
Joint Swelling 4 4
Test Result 4 4
Pressure Sores 4 4
Congenital Defect/Deformity 4 4
Neuropathy 4 4
Toxicity 3 3
Fluid Discharge 3 3
Insufficient Information 3 3
Foreign Body Reaction 3 3
Tingling 3 3
Weakness 3 3
Myocardial Infarction 3 3
Nausea 3 3
Local Reaction 2 2
Muscular Rigidity 2 2
Bruise/Contusion 2 2
Adhesion(s) 2 2
Debris, Bone Shedding 2 2
Purulent Discharge 2 2
Edema 2 2
Embolism 2 2
Radiation Exposure, Unintended 2 2
Alteration In Body Temperature 2 2
Internal Organ Perforation 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biomet, Inc. II May-26-2016
2 CarboFix Orthopedics, Ltd. II Jun-14-2016
3 Integra LifeSciences Corp. II Mar-23-2017
4 Nuvasive Specialized Orthopedics Inc II Oct-07-2020
5 Ortho Solutions Inc II Jul-28-2017
6 OrthoPediatrics Corp II Oct-25-2019
7 OrthoPediatrics Corp II Oct-13-2019
8 OrthoPediatrics Corp III Dec-22-2016
9 Pega Medical Inc. II Aug-14-2019
10 Pega Medical Inc. II Apr-29-2015
11 Pega Medical Inc. II Apr-02-2015
12 Stryker GmbH II Jun-16-2020
13 Stryker GmbH II Aug-22-2018
14 Stryker GmbH II Jul-10-2018
15 Stryker Howmedica Osteonics Corp. II Sep-13-2016
16 Stryker Howmedica Osteonics Corp. II Feb-25-2016
17 Synthes (USA) Products LLC II Feb-13-2018
18 Synthes (USA) Products LLC II Nov-19-2016
19 Synthes (USA) Products LLC II Dec-04-2015
20 Synthes (USA) Products LLC II Oct-15-2015
21 Synthes (USA) Products LLC II Jul-16-2015
22 Synthes, Inc. II Jun-26-2015
23 Synthes, Inc. II May-12-2015
24 Synthes, Inc. II Mar-30-2015
25 Tornier, Inc II Jul-29-2015
26 Vilex In Tennessee Inc II Jun-08-2015
27 Wright Medical Technology, Inc. II Nov-25-2019
28 Wright Medical Technology, Inc. II Apr-13-2018
29 Zimmer Biomet, Inc. II Nov-07-2019
30 Zimmer Biomet, Inc. II Nov-14-2018
31 Zimmer Biomet, Inc. II Oct-18-2018
32 Zimmer Biomet, Inc. II Sep-25-2018
33 Zimmer Biomet, Inc. II Sep-13-2018
34 Zimmer Biomet, Inc. II Apr-25-2018
35 Zimmer Biomet, Inc. II Apr-20-2018
36 Zimmer Biomet, Inc. II Mar-27-2018
37 Zimmer Biomet, Inc. II Mar-14-2018
38 Zimmer Biomet, Inc. II Mar-14-2018
39 Zimmer Biomet, Inc. II Jan-29-2018
40 Zimmer Biomet, Inc. II Jun-15-2017
41 Zimmer Biomet, Inc. II Jun-01-2017
42 Zimmer Biomet, Inc. II Mar-20-2017
43 Zimmer Gmbh II Oct-14-2015
44 Zimmer Manufacturing B.V. II May-16-2016
45 Zimmer Manufacturing B.V. II Mar-12-2016
46 Zimmer, Inc. II Jul-13-2015
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