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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
2018 4685 4685
2019 5224 5233
2020 4766 4771
2021 4833 4884
2022 4843 4911
2023 4254 4267

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11237 11237
Device-Device Incompatibility 3732 3732
Fracture 2781 2812
Material Deformation 1415 1453
Material Twisted/Bent 1292 1292
Detachment of Device or Device Component 1237 1237
Crack 1155 1155
Naturally Worn 1104 1104
Mechanical Jam 851 897
Scratched Material 834 834
Mechanical Problem 620 620
Calibration Problem 472 472
Adverse Event Without Identified Device or Use Problem 471 473
Appropriate Term/Code Not Available 413 413
Material Fragmentation 356 356
Material Integrity Problem 353 353
Corroded 309 315
Contamination /Decontamination Problem 263 263
Mechanics Altered 250 250
Difficult to Remove 245 245
Physical Resistance/Sticking 242 242
Component Missing 220 220
Loose or Intermittent Connection 216 216
Entrapment of Device 205 205
Unintended Movement 194 194
Use of Device Problem 177 177
Illegible Information 154 154
Dull, Blunt 146 146
Connection Problem 145 145
Insufficient Information 140 140
Compatibility Problem 137 137
Device Operates Differently Than Expected 136 136
Difficult to Open or Close 130 130
Device Contamination with Chemical or Other Material 116 116
Failure to Align 108 108
Material Discolored 104 104
Material Separation 102 102
Degraded 99 99
Device Slipped 97 97
Defective Device 93 93
Bent 89 89
Positioning Failure 75 75
Material Split, Cut or Torn 74 74
Difficult to Insert 72 72
No Apparent Adverse Event 68 68
Detachment Of Device Component 66 66
Manufacturing, Packaging or Shipping Problem 56 56
Separation Failure 54 54
Flaked 52 52
Device Dislodged or Dislocated 52 52
Positioning Problem 52 52
Failure to Advance 50 50
Improper or Incorrect Procedure or Method 50 50
Device Damaged Prior to Use 47 47
Difficult to Advance 47 47
Fitting Problem 44 44
Unstable 39 39
Deformation Due to Compressive Stress 39 50
Device Damaged by Another Device 38 38
Peeled/Delaminated 37 37
Device Markings/Labelling Problem 35 35
Material Disintegration 33 33
Difficult or Delayed Separation 33 33
Device Difficult to Setup or Prepare 32 32
Solder Joint Fracture 30 30
Device Fell 30 30
Structural Problem 27 27
Metal Shedding Debris 26 26
Device Contaminated During Manufacture or Shipping 26 26
Failure to Cut 25 25
Activation, Positioning or Separation Problem 24 24
Incorrect Measurement 24 24
Incomplete or Inadequate Connection 23 23
Patient Device Interaction Problem 23 23
Migration or Expulsion of Device 22 22
Display Difficult to Read 22 22
Defective Component 22 22
Difficult or Delayed Positioning 21 21
Residue After Decontamination 20 20
Inadequacy of Device Shape and/or Size 20 20
Device Issue 19 19
Failure to Disconnect 19 19
Problem with Sterilization 18 18
Device Reprocessing Problem 18 18
Migration 18 18
Device Difficult to Maintain 18 18
Separation Problem 17 17
Failure to Clean Adequately 17 17
Nonstandard Device 17 17
Delivered as Unsterile Product 16 16
Off-Label Use 16 16
Failure to Eject 16 42
Packaging Problem 16 16
Output Problem 15 15
Loosening of Implant Not Related to Bone-Ingrowth 14 14
Patient-Device Incompatibility 14 14
Device Handling Problem 13 13
Noise, Audible 12 12
Malposition of Device 12 12
Device Operational Issue 12 12

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 13215 13347
No Consequences Or Impact To Patient 8274 8288
No Known Impact Or Consequence To Patient 2506 2506
No Patient Involvement 1019 1019
Foreign Body In Patient 887 887
No Code Available 814 814
Insufficient Information 780 782
Not Applicable 467 467
No Information 364 364
Device Embedded In Tissue or Plaque 364 364
Bone Fracture(s) 155 155
Injury 130 130
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 106 106
Pain 101 101
Failure of Implant 94 94
Unspecified Infection 82 82
Tissue Damage 52 52
Unspecified Tissue Injury 49 49
Loss of Range of Motion 28 28
Nerve Damage 26 26
Laceration(s) 24 24
Non-union Bone Fracture 22 22
Hemorrhage/Bleeding 19 19
Inflammation 17 17
Patient Problem/Medical Problem 15 15
Swelling/ Edema 15 15
Pulmonary Embolism 14 14
Death 13 13
Post Operative Wound Infection 13 13
Blood Loss 12 12
Hip Fracture 12 12
Perforation 12 12
Muscle/Tendon Damage 12 12
Joint Dislocation 11 11
Discomfort 10 10
Fluid Discharge 10 10
Limb Fracture 10 10
Ambulation Difficulties 9 9
Rupture 9 9
Perforation of Vessels 8 8
Paralysis 8 8
Bacterial Infection 8 8
Implant Pain 8 8
Joint Laxity 7 7
Burn(s) 7 7
Hematoma 7 7
Weakness 7 7
Scar Tissue 7 7
Arthralgia 7 7
Numbness 7 7
Spinal Cord Injury 6 6
Muscular Rigidity 6 6
Necrosis 6 6
Foreign Body Reaction 6 6
Neurological Deficit/Dysfunction 5 5
Osteolysis 5 5
Impaired Healing 5 5
Reaction 5 5
Spinal Column Injury 5 5
Disc Impingement 5 5
Inadequate Osseointegration 4 4
Limited Mobility Of The Implanted Joint 4 4
Swelling 4 4
Deformity/ Disfigurement 4 4
Damage to Ligament(s) 4 4
Cardiac Arrest 4 4
Arthritis 3 3
Abscess 3 3
Adhesion(s) 3 3
Vessel Or Plaque, Device Embedded In 3 3
Fall 3 3
Connective Tissue Disease 3 3
Purulent Discharge 3 3
Muscle Weakness 3 3
Infiltration into Tissue 3 3
Neuropathy 3 3
Myocardial Infarction 3 3
Local Reaction 3 3
Skin Irritation 3 3
Osteopenia/ Osteoporosis 3 3
Paraplegia 2 2
Quadriplegia 2 2
Needle Stick/Puncture 2 2
Intraoperative Pain 2 2
Paresthesia 2 2
Seroma 2 2
Great Vessel Perforation 2 2
Joint Disorder 2 2
Thrombosis 2 2
Rash 2 2
Internal Organ Perforation 2 2
Overdose 2 2
Irritation 2 2
Headache 2 2
Dysphagia/ Odynophagia 2 2
Cellulitis 2 2
Cerebrospinal Fluid Leakage 2 2
Exsanguination 2 2
Extravasation 2 2
Wound Dehiscence 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Ad-Tech Medical Instrument Corporation II May-25-2018
2 Aesculap Implant Systems LLC II Jul-21-2022
3 Aesculap Implant Systems LLC II Jul-21-2022
4 Aesculap Implant Systems LLC II Jul-15-2022
5 Arthrex, Inc. II May-05-2022
6 Arthrex, Inc. II Jan-30-2020
7 Biomet II Jun-12-2020
8 ConMed Corporation II Apr-27-2021
9 ConMed Corporation II Dec-21-2020
10 DePuy Mitek, Inc., a Johnson & Johnson Co. II Oct-23-2018
11 DePuy Mitek, Inc., a Johnson & Johnson Co. II May-08-2018
12 DePuy Orthopaedics, Inc. II Apr-11-2019
13 DePuy Orthopaedics, Inc. II Mar-02-2018
14 Encore Medical, Lp II Dec-06-2019
15 Exactech, Inc. II Oct-11-2018
16 Howmedica Osteonics Corp. II Jun-14-2023
17 Howmedica Osteonics Corp. II Dec-21-2018
18 Howmedica Osteonics Corp. II Nov-02-2018
19 Howmedica Osteonics Corp. II Oct-23-2018
20 Howmedica Osteonics Corp. II Mar-01-2018
21 In2bones USA, LLC II Sep-22-2021
22 K2M, Inc II Dec-07-2020
23 Laboratoires Bodycad, Inc. II Nov-17-2021
24 Medacta Usa Inc II Jun-07-2022
25 Medtronic Sofamor Danek USA Inc II May-10-2023
26 Mizuho OSI II Aug-24-2022
27 OMNIlife science Inc. II Feb-14-2019
28 Pega Medical Inc. III May-15-2020
29 Pega Medical Inc. II Nov-01-2019
30 SONEX HEALTH LLC II Jul-15-2022
31 Smith & Nephew, Inc. II Aug-10-2020
32 Smith & Nephew, Inc. II Nov-08-2019
33 Smith & Nephew, Inc. II Jan-12-2019
34 Stryker Instruments Div. of Stryker Corporation II Mar-28-2018
35 Synthes (USA) Products LLC II Feb-10-2022
36 Synthes, Inc. II Apr-24-2018
37 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
38 TeDan Surgical Innovations LLC II Jul-10-2020
39 TeDan Surgical Innovations LLC II Mar-17-2020
40 Tornier, Inc II Jun-01-2022
41 TriMed Inc. II Nov-12-2019
42 TriMed Inc. II Apr-12-2018
43 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-29-2023
44 Zimmer Biomet, Inc. II Jun-02-2020
45 Zimmer Biomet, Inc. II Jan-28-2020
46 Zimmer Biomet, Inc. II Dec-03-2019
47 Zimmer Biomet, Inc. II Nov-22-2019
48 Zimmer Biomet, Inc. II Nov-07-2019
49 Zimmer Biomet, Inc. II Jul-04-2019
50 Zimmer Biomet, Inc. II Jun-19-2019
51 Zimmer Biomet, Inc. II Jun-06-2019
52 Zimmer Biomet, Inc. II Nov-30-2018
53 Zimmer Biomet, Inc. II Aug-18-2018
54 Zimmer Biomet, Inc. II Aug-17-2018
55 Zimmer Biomet, Inc. II Apr-20-2018
56 Zimmer Biomet, Inc. II Mar-28-2018
57 Zimmer Biomet, Inc. II Mar-06-2018
58 Zimmer Biomet, Inc. II Feb-27-2018
59 Zimmer Biomet, Inc. II Feb-07-2018
60 Zimmer Biomet, Inc. II Feb-04-2018
61 restor3d Inc. II Apr-29-2022
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