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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
2019 5224 5233
2020 4766 4771
2021 4833 4884
2022 4844 4912
2023 5182 5195
2024 1395 1395

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10132 10132
Device-Device Incompatibility 3855 3855
Fracture 2684 2715
Material Deformation 1383 1421
Material Twisted/Bent 1239 1239
Detachment of Device or Device Component 1217 1217
Naturally Worn 1039 1039
Crack 900 900
Mechanical Jam 729 775
Scratched Material 610 610
Mechanical Problem 577 577
Calibration Problem 494 494
Adverse Event Without Identified Device or Use Problem 427 429
Material Integrity Problem 378 378
Material Fragmentation 354 354
Physical Resistance/Sticking 348 348
Corroded 314 320
Contamination /Decontamination Problem 303 303
Mechanics Altered 262 262
Unintended Movement 209 209
Use of Device Problem 201 201
Appropriate Term/Code Not Available 200 200
Entrapment of Device 178 178
Loose or Intermittent Connection 167 167
Difficult to Remove 163 163
Illegible Information 158 158
Difficult to Open or Close 155 155
Component Missing 150 150
Compatibility Problem 147 147
Connection Problem 118 118
Dull, Blunt 111 111
Material Separation 105 105
Insufficient Information 103 103
Degraded 100 100
Defective Device 99 99
No Apparent Adverse Event 99 99
Failure to Align 93 93
Material Discolored 87 87
Device Slipped 85 85
Positioning Failure 71 71
Material Split, Cut or Torn 67 67
Device Contamination with Chemical or Other Material 61 61
Difficult to Insert 57 57
Flaked 54 54
Failure to Advance 54 54
Device Dislodged or Dislocated 50 50
Manufacturing, Packaging or Shipping Problem 49 49
Unstable 48 48
Difficult to Advance 47 47
Improper or Incorrect Procedure or Method 45 45
Deformation Due to Compressive Stress 36 47
Difficult or Delayed Separation 36 36
Device Damaged Prior to Use 35 35
Separation Failure 34 34
Positioning Problem 33 33
Device Difficult to Setup or Prepare 32 32
Peeled/Delaminated 31 31
Fitting Problem 31 31
Device Damaged by Another Device 30 30
Structural Problem 29 29
Material Disintegration 29 29
Solder Joint Fracture 28 28
Device Contaminated During Manufacture or Shipping 28 28
Device Markings/Labelling Problem 27 27
Patient Device Interaction Problem 27 27
Failure to Cut 25 25
Activation, Positioning or Separation Problem 23 23
Device Fell 23 23
Loosening of Implant Not Related to Bone-Ingrowth 22 22
Display Difficult to Read 22 22
Incorrect Measurement 22 22
Difficult or Delayed Positioning 21 21
Migration 21 21
Incomplete or Inadequate Connection 21 21
Migration or Expulsion of Device 20 20
Problem with Sterilization 17 17
Defective Component 17 17
Failure to Eject 17 43
Device Difficult to Maintain 17 17
Failure to Clean Adequately 17 17
Residue After Decontamination 16 16
Off-Label Use 16 16
Delivered as Unsterile Product 15 15
Output Problem 15 15
Product Quality Problem 13 13
Inadequacy of Device Shape and/or Size 12 12
Malposition of Device 12 12
Packaging Problem 12 12
Failure to Disconnect 11 11
Human-Device Interface Problem 11 11
Nonstandard Device 11 11
Material Protrusion/Extrusion 10 10
Patient-Device Incompatibility 10 10
Device Handling Problem 10 10
Noise, Audible 10 10
Inaccurate Information 10 10
Component Misassembled 9 9
Loss of Osseointegration 9 9
Component or Accessory Incompatibility 9 9
Unsealed Device Packaging 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15030 15162
No Consequences Or Impact To Patient 5512 5526
No Known Impact Or Consequence To Patient 1586 1586
Insufficient Information 1139 1141
Foreign Body In Patient 852 852
No Patient Involvement 766 766
No Code Available 594 594
Not Applicable 331 331
Device Embedded In Tissue or Plaque 274 274
No Information 160 160
Bone Fracture(s) 135 135
Injury 106 106
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 106 106
Failure of Implant 105 105
Pain 89 89
Unspecified Infection 70 70
Unspecified Tissue Injury 53 53
Tissue Damage 39 39
Loss of Range of Motion 30 30
Nerve Damage 26 26
Laceration(s) 25 25
Joint Dislocation 23 23
Non-union Bone Fracture 20 20
Hemorrhage/Bleeding 19 19
Inflammation 17 17
Perforation 15 15
Swelling/ Edema 15 15
Spinal Column Injury 14 14
Muscle/Tendon Damage 14 14
Limb Fracture 12 12
Subluxation 11 11
Patient Problem/Medical Problem 11 11
Post Operative Wound Infection 11 11
Fluid Discharge 10 10
Rheumatoid Arthritis 10 10
Joint Laxity 9 9
Ambulation Difficulties 9 9
Blood Loss 9 9
Rupture 8 8
Implant Pain 8 8
Bacterial Infection 8 8
Hypersensitivity/Allergic reaction 8 8
Burn(s) 7 7
Hip Fracture 7 7
Discomfort 7 7
Arthralgia 7 7
Osteolysis 6 6
Weakness 6 6
Numbness 6 6
Spinal Cord Injury 6 6
Paralysis 6 6
Scar Tissue 6 6
Perforation of Vessels 6 6
Hematoma 6 6
Muscular Rigidity 6 6
Neurological Deficit/Dysfunction 5 5
Necrosis 5 5
Osteopenia/ Osteoporosis 5 5
Disc Impingement 5 5
Impaired Healing 5 5
Reaction 5 5
Deformity/ Disfigurement 4 4
Limited Mobility Of The Implanted Joint 4 4
Inadequate Osseointegration 4 4
Fall 4 4
Foreign Body Reaction 4 4
Connective Tissue Disease 3 3
Purulent Discharge 3 3
Vessel Or Plaque, Device Embedded In 3 3
Abscess 3 3
Adhesion(s) 3 3
Neuropathy 3 3
Myocardial Infarction 3 3
Damage to Ligament(s) 3 3
Muscle Weakness 3 3
Infiltration into Tissue 3 3
Irritation 2 2
Headache 2 2
Internal Organ Perforation 2 2
Overdose 2 2
Rash 2 2
Swelling 2 2
Synovitis 2 2
Thrombosis 2 2
Pulmonary Embolism 2 2
Wound Dehiscence 2 2
Cardiac Arrest 2 2
Cellulitis 2 2
Cerebrospinal Fluid Leakage 2 2
Dysphagia/ Odynophagia 2 2
Exsanguination 2 2
Intraoperative Pain 2 2
Paraplegia 2 2
Quadriplegia 2 2
Needle Stick/Puncture 2 2
Great Vessel Perforation 2 2
Seroma 2 2
Neuralgia 2 2
Paresthesia 2 2
External Prosthetic Device Pain 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Dec-26-2023
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 Orthopaedics, Inc. II Apr-11-2019
11 Encore Medical, Lp II Dec-06-2019
12 Howmedica Osteonics Corp. II Feb-06-2024
13 Howmedica Osteonics Corp. II Jun-14-2023
14 In2bones USA, LLC II Sep-22-2021
15 K2M, Inc II Dec-07-2020
16 Laboratoires Bodycad, Inc. II Nov-17-2021
17 Medacta Usa Inc II Jun-07-2022
18 Medtronic Sofamor Danek USA Inc II May-10-2023
19 Mizuho OSI II Aug-24-2022
20 OMNIlife science Inc. II Feb-14-2019
21 Pega Medical Inc. III May-15-2020
22 Pega Medical Inc. II Nov-01-2019
23 SONEX HEALTH LLC II Jul-15-2022
24 Smith & Nephew, Inc. II Aug-10-2020
25 Smith & Nephew, Inc. II Nov-08-2019
26 Smith & Nephew, Inc. II Jan-12-2019
27 Stryker Spine II Dec-21-2023
28 Synthes (USA) Products LLC II Feb-10-2022
29 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
30 TeDan Surgical Innovations LLC II Jul-10-2020
31 TeDan Surgical Innovations LLC II Mar-17-2020
32 Tornier, Inc II Jun-01-2022
33 TriMed Inc. II Nov-12-2019
34 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-29-2023
35 Zimmer Biomet, Inc. II Jun-02-2020
36 Zimmer Biomet, Inc. II Jan-28-2020
37 Zimmer Biomet, Inc. II Dec-03-2019
38 Zimmer Biomet, Inc. II Nov-22-2019
39 Zimmer Biomet, Inc. II Nov-07-2019
40 Zimmer Biomet, Inc. II Jul-04-2019
41 Zimmer Biomet, Inc. II Jun-19-2019
42 Zimmer Biomet, Inc. II Jun-06-2019
43 restor3d Inc. II Apr-29-2022
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