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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device orthopedic manual surgical instrument
Product CodeLXH
Regulation Number 888.4540
Device Class 1


Premarket Reviews
ManufacturerDecision
SONEX HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 4132 4132
2018 4687 4687
2019 5224 5233
2020 4766 4771
2021 4799 4850

Device Problems MDRs with this Device Problem Events in those MDRs
Break 9636 9636
Fracture 2162 2166
Device-Device Incompatibility 2133 2133
Material Twisted/Bent 1171 1171
Crack 1163 1163
Material Deformation 1008 1023
Scratched Material 830 830
Naturally Worn 763 763
Mechanical Jam 738 773
Appropriate Term/Code Not Available 623 623
Mechanical Problem 573 573
Detachment of Device or Device Component 417 417
Adverse Event Without Identified Device or Use Problem 383 383
Material Fragmentation 360 360
Device Operates Differently Than Expected 316 316
Material Integrity Problem 306 306
Calibration Problem 300 300
Component Missing 277 277
Difficult to Remove 270 270
Loose or Intermittent Connection 242 242
Corroded 224 224
Physical Resistance/Sticking 210 210
Bent 199 199
Insufficient Information 194 194
Connection Problem 183 183
Detachment Of Device Component 180 180
Entrapment of Device 163 163
Contamination /Decontamination Problem 150 150
Mechanics Altered 145 145
Illegible Information 143 143
Device Contamination with Chemical or Other Material 132 132
Dull, Blunt 132 132
Failure to Align 128 128
Material Discolored 109 109
Unintended Movement 99 99
Fitting Problem 94 94
Use of Device Problem 93 93
Defective Device 85 85
Compatibility Problem 85 85
Difficult to Insert 78 78
Disassembly 77 77
Material Separation 73 73
Separation Failure 71 71
Device Slipped 70 70
Degraded 65 65
Difficult to Open or Close 64 64
Device Dislodged or Dislocated 57 57
Positioning Problem 57 57
Positioning Failure 56 56
Device Damaged Prior to Use 48 48
Peeled/Delaminated 42 42
Metal Shedding Debris 40 40
Failure to Advance 40 40
Sticking 38 38
Device Damaged by Another Device 35 35
Device Markings/Labelling Problem 35 35
Material Disintegration 34 34
Improper or Incorrect Procedure or Method 32 32
Defective Component 31 31
Device Issue 31 31
Difficult to Advance 31 31
No Apparent Adverse Event 31 31
Deformation Due to Compressive Stress 30 41
Residue After Decontamination 30 30
Failure To Adhere Or Bond 29 29
Nonstandard Device 28 28
Device Fell 28 28
Material Split, Cut or Torn 28 28
Device Reprocessing Problem 26 26
Migration or Expulsion of Device 23 23
Solder Joint Fracture 23 23
Incomplete or Inadequate Connection 23 23
Activation, Positioning or SeparationProblem 22 22
Display Difficult to Read 22 22
Failure to Cut 21 21
Difficult or Delayed Separation 21 21
Device Difficult to Maintain 21 21
Packaging Problem 20 20
Device Inoperable 20 20
Unstable 20 20
Flaked 20 20
Difficult or Delayed Positioning 20 20
Inadequacy of Device Shape and/or Size 19 19
Failure to Disconnect 19 19
Device Handling Problem 18 18
Manufacturing, Packaging or Shipping Problem 18 18
Device Operational Issue 17 17
Patient Device Interaction Problem 17 17
Component Falling 17 17
Misconnection 16 16
Delivered as Unsterile Product 16 16
Patient-Device Incompatibility 16 16
Device Contaminated During Manufacture or Shipping 16 16
Separation Problem 15 15
Problem with Sterilization 15 15
Difficult To Position 15 15
Device Difficult to Setup or Prepare 14 14
Failure to Clean Adequately 14 14
Incorrect Measurement 13 13
Structural Problem 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 8925 8939
No Clinical Signs, Symptoms or Conditions 5139 5192
No Known Impact Or Consequence To Patient 4237 4237
No Information 1677 1677
No Patient Involvement 1230 1230
No Code Available 920 920
Foreign Body In Patient 666 666
Not Applicable 494 494
Device Embedded In Tissue or Plaque 448 448
Insufficient Information 310 310
Bone Fracture(s) 180 180
Injury 154 154
Failure of Implant 83 83
Pain 83 83
Unspecified Infection 73 73
Tissue Damage 58 58
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 33 33
Unspecified Tissue Injury 28 28
Blood Loss 17 17
Patient Problem/Medical Problem 16 16
Loss of Range of Motion 15 15
Inflammation 15 15
Pulmonary Embolism 14 14
Hip Fracture 14 14
Death 13 13
Hemorrhage/Bleeding 12 12
Non-union Bone Fracture 12 12
Joint Disorder 11 11
Discomfort 9 9
Nerve Damage 9 9
Paralysis 8 8
Swelling 7 7
Weakness 7 7
Joint Dislocation 7 7
Post Operative Wound Infection 7 7
Ambulation Difficulties 7 7
Reaction 6 6
Foreign Body Reaction 6 6
Perforation of Vessels 5 5
Perforation 5 5
Scar Tissue 5 5
Neurological Deficit/Dysfunction 5 5
Hematoma 5 5
Necrosis 5 5
Laceration(s) 5 5
Impaired Healing 5 5
Disc Impingement 5 5
Fluid Discharge 5 5
Limb Fracture 4 4
Limited Mobility Of The Implanted Joint 4 4
Osteolysis 4 4
Arthralgia 4 4
Muscular Rigidity 4 4
Local Reaction 4 4
Spinal Column Injury 4 4
Burn(s) 4 4
Cardiac Arrest 4 4
Vessel Or Plaque, Device Embedded In 4 4
Arthritis 4 4
Abscess 3 3
Adhesion(s) 3 3
Bacterial Infection 3 3
Skin Irritation 3 3
Synovitis 3 3
Myocardial Infarction 3 3
Damage to Ligament(s) 3 3
Irritation 3 3
Rupture 3 3
Inadequate Osseointegration 3 3
Nervous System Injury 3 3
Joint Laxity 3 3
Swelling/ Edema 3 3
Muscle/Tendon Damage 2 2
External Prosthetic Device Pain 2 2
Radiation Exposure, Unintended 2 2
Intraoperative Pain 2 2
Osteopenia/ Osteoporosis 2 2
Spinal Cord Injury 2 2
Deformity/ Disfigurement 2 2
Numbness 2 2
Itching Sensation 2 2
Muscle Weakness 2 2
Internal Organ Perforation 2 2
Overdose 2 2
Thrombosis 2 2
Rash 2 2
Hypersensitivity/Allergic reaction 2 2
Dysphagia/ Odynophagia 2 2
Exsanguination 2 2
Extravasation 2 2
Fall 2 2
Cerebrospinal Fluid Leakage 2 2
Coagulation Disorder 1 1
Contusion 1 1
Debris, Bone Shedding 1 1
Cardiopulmonary Arrest 1 1
Cellulitis 1 1
Awareness during Anaesthesia 1 1
Atrial Fibrillation 1 1
Atrial Tachycardia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Mar-16-2017
2 Ad-Tech Medical Instrument Corporation II May-25-2018
3 Amendia, Inc II Apr-25-2017
4 Arthrex, Inc. II Jan-30-2020
5 Biomet II Jun-12-2020
6 Biomet U.K., Ltd. II Feb-22-2017
7 ConMed Corporation II Apr-27-2021
8 ConMed Corporation II Dec-21-2020
9 DePuy Mitek, Inc., a Johnson & Johnson Co. II Oct-23-2018
10 DePuy Mitek, Inc., a Johnson & Johnson Co. II May-08-2018
11 DePuy Orthopaedics, Inc. II Apr-11-2019
12 DePuy Orthopaedics, Inc. II Mar-02-2018
13 DePuy Orthopaedics, Inc. II Jun-08-2017
14 Encore Medical, Lp II Dec-06-2019
15 Exactech, Inc. II Oct-11-2018
16 Exactech, Inc. II Jun-19-2017
17 Exactech, Inc. II Jun-19-2017
18 Flower Orthopedics Corporation II Jan-28-2017
19 Greatbatch Medical II Feb-11-2017
20 Howmedica Osteonics Corp. II Dec-21-2018
21 Howmedica Osteonics Corp. II Nov-02-2018
22 Howmedica Osteonics Corp. II Oct-23-2018
23 Howmedica Osteonics Corp. II Mar-01-2018
24 Implant Direct Sybron Manufacturing, LLC II Sep-11-2017
25 In2bones USA, LLC II Sep-22-2021
26 K2M, Inc II Dec-07-2020
27 Laboratoires Bodycad, Inc. II Nov-17-2021
28 Limacorporate S.p.A II Nov-06-2017
29 MEDLINE INDUSTRIES INC II May-17-2017
30 Medtronic Sofamor Danek USA Inc II May-05-2017
31 OMNIlife science Inc. II Feb-14-2019
32 Pega Medical Inc. III May-15-2020
33 Pega Medical Inc. II Nov-01-2019
34 Smith & Nephew, Inc. II Aug-10-2020
35 Smith & Nephew, Inc. II Nov-08-2019
36 Smith & Nephew, Inc. II Jan-12-2019
37 Stryker Howmedica Osteonics Corp. II Jan-12-2017
38 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
39 Synthes (USA) Products LLC II Feb-27-2017
40 Synthes, Inc. II Apr-24-2018
41 TeDan Surgical Innovations LLC II Jul-10-2020
42 TeDan Surgical Innovations LLC II Mar-17-2020
43 TriMed Inc. II Nov-12-2019
44 TriMed Inc. II Apr-12-2018
45 United Orthopedic Corporation II Mar-01-2017
46 Vertebral Technologies, Inc. II Feb-08-2017
47 Zimmer Biomet, Inc. II Jun-02-2020
48 Zimmer Biomet, Inc. II Jan-28-2020
49 Zimmer Biomet, Inc. II Dec-03-2019
50 Zimmer Biomet, Inc. II Nov-22-2019
51 Zimmer Biomet, Inc. II Nov-07-2019
52 Zimmer Biomet, Inc. II Jul-04-2019
53 Zimmer Biomet, Inc. II Jun-19-2019
54 Zimmer Biomet, Inc. II Jun-06-2019
55 Zimmer Biomet, Inc. II Nov-30-2018
56 Zimmer Biomet, Inc. II Aug-18-2018
57 Zimmer Biomet, Inc. II Aug-17-2018
58 Zimmer Biomet, Inc. II Apr-20-2018
59 Zimmer Biomet, Inc. II Mar-28-2018
60 Zimmer Biomet, Inc. II Mar-06-2018
61 Zimmer Biomet, Inc. II Feb-27-2018
62 Zimmer Biomet, Inc. II Feb-07-2018
63 Zimmer Biomet, Inc. II Feb-04-2018
64 Zimmer Biomet, Inc. II Apr-25-2017
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