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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 3554 3567

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10976 10976
Device-Device Incompatibility 3628 3628
Fracture 2693 2724
Material Deformation 1370 1408
Material Twisted/Bent 1282 1282
Detachment of Device or Device Component 1221 1221
Crack 1135 1135
Naturally Worn 1051 1051
Mechanical Jam 840 886
Scratched Material 833 833
Mechanical Problem 615 615
Calibration Problem 462 462
Adverse Event Without Identified Device or Use Problem 458 460
Appropriate Term/Code Not Available 407 407
Material Fragmentation 350 350
Material Integrity Problem 345 345
Corroded 287 293
Difficult to Remove 243 243
Mechanics Altered 241 241
Contamination /Decontamination Problem 240 240
Physical Resistance/Sticking 234 234
Component Missing 220 220
Loose or Intermittent Connection 215 215
Entrapment of Device 201 201
Unintended Movement 187 187
Use of Device Problem 164 164
Illegible Information 153 153
Connection Problem 145 145
Dull, Blunt 138 138
Insufficient Information 138 138
Device Operates Differently Than Expected 136 136
Compatibility Problem 130 130
Difficult to Open or Close 126 126
Device Contamination with Chemical or Other Material 116 116
Failure to Align 108 108
Material Discolored 104 104
Material Separation 101 101
Degraded 99 99
Device Slipped 97 97
Bent 89 89
Defective Device 83 83
Difficult to Insert 72 72
Positioning Failure 71 71
Material Split, Cut or Torn 68 68
No Apparent Adverse Event 67 67
Detachment Of Device Component 66 66
Flaked 52 52
Separation Failure 52 52
Device Dislodged or Dislocated 52 52
Positioning Problem 52 52
Failure to Advance 47 47
Device Damaged Prior to Use 47 47
Difficult to Advance 45 45
Fitting Problem 44 44
Deformation Due to Compressive Stress 39 50
Device Damaged by Another Device 38 38
Peeled/Delaminated 37 37
Improper or Incorrect Procedure or Method 36 36
Unstable 35 35
Device Markings/Labelling Problem 33 33
Material Disintegration 33 33
Difficult or Delayed Separation 33 33
Device Difficult to Setup or Prepare 31 31
Device Fell 30 30
Solder Joint Fracture 29 29
Metal Shedding Debris 26 26
Manufacturing, Packaging or Shipping Problem 26 26
Structural Problem 25 25
Activation, Positioning or Separation Problem 24 24
Incorrect Measurement 24 24
Device Contaminated During Manufacture or Shipping 24 24
Incomplete or Inadequate Connection 23 23
Patient Device Interaction Problem 22 22
Migration or Expulsion of Device 22 22
Display Difficult to Read 22 22
Failure to Cut 22 22
Defective Component 22 22
Difficult or Delayed Positioning 21 21
Inadequacy of Device Shape and/or Size 20 20
Device Issue 19 19
Failure to Disconnect 19 19
Residue After Decontamination 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
Output Problem 15 15
Problem with Sterilization 15 15
Patient-Device Incompatibility 14 14
Packaging Problem 14 14
Device Handling Problem 13 13
Noise, Audible 12 12
Loosening of Implant Not Related to Bone-Ingrowth 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 12628 12760
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 855 855
No Code Available 814 814
Insufficient Information 704 706
Not Applicable 467 467
No Information 364 364
Device Embedded In Tissue or Plaque 362 362
Bone Fracture(s) 154 154
Injury 130 130
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 103 103
Pain 95 95
Failure of Implant 92 92
Unspecified Infection 75 75
Tissue Damage 52 52
Unspecified Tissue Injury 48 48
Loss of Range of Motion 27 27
Nerve Damage 25 25
Laceration(s) 22 22
Non-union Bone Fracture 22 22
Hemorrhage/Bleeding 20 20
Inflammation 16 16
Patient Problem/Medical Problem 15 15
Pulmonary Embolism 14 14
Swelling/ Edema 14 14
Muscle/Tendon Damage 13 13
Death 13 13
Post Operative Wound Infection 13 13
Hip Fracture 12 12
Blood Loss 12 12
Joint Dislocation 11 11
Discomfort 10 10
Limb Fracture 10 10
Perforation 10 10
Ambulation Difficulties 9 9
Fluid Discharge 9 9
Rupture 8 8
Perforation of Vessels 8 8
Paralysis 8 8
Implant Pain 8 8
Joint Laxity 7 7
Scar Tissue 7 7
Hematoma 7 7
Burn(s) 7 7
Weakness 7 7
Arthralgia 7 7
Numbness 7 7
Spinal Cord Injury 6 6
Bacterial Infection 6 6
Foreign Body Reaction 6 6
Necrosis 6 6
Muscular Rigidity 6 6
Spinal Column Injury 5 5
Neurological Deficit/Dysfunction 5 5
Disc Impingement 5 5
Osteolysis 5 5
Impaired Healing 5 5
Reaction 5 5
Deformity/ Disfigurement 4 4
Swelling 4 4
Inadequate Osseointegration 4 4
Limited Mobility Of The Implanted Joint 4 4
Damage to Ligament(s) 4 4
Cardiac Arrest 4 4
Arthritis 3 3
Vessel Or Plaque, Device Embedded In 3 3
Abscess 3 3
Adhesion(s) 3 3
Fall 3 3
Purulent Discharge 3 3
Muscle Weakness 3 3
Neuropathy 3 3
Infiltration into Tissue 3 3
Local Reaction 3 3
Myocardial Infarction 3 3
Osteopenia/ Osteoporosis 3 3
Skin Irritation 3 3
Thrombosis 2 2
Joint Disorder 2 2
Paraplegia 2 2
Quadriplegia 2 2
Needle Stick/Puncture 2 2
Intraoperative Pain 2 2
Hyperextension 2 2
Paresthesia 2 2
Neuralgia 2 2
Rash 2 2
Internal Organ Perforation 2 2
Overdose 2 2
Irritation 2 2
Dysphagia/ Odynophagia 2 2
Exsanguination 2 2
Extravasation 2 2
Headache 2 2
Wound Dehiscence 2 2
Cellulitis 2 2
Cerebrospinal Fluid Leakage 2 2
Malunion of Bone 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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