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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 4845 4913
2023 5183 5196
2024 3534 3534

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10820 10820
Device-Device Incompatibility 4065 4065
Fracture 2906 2937
Material Deformation 1454 1492
Material Twisted/Bent 1317 1317
Detachment of Device or Device Component 1273 1273
Naturally Worn 1226 1226
Crack 931 931
Mechanical Jam 785 831
Scratched Material 613 613
Mechanical Problem 595 595
Physical Resistance/Sticking 527 527
Calibration Problem 497 497
Adverse Event Without Identified Device or Use Problem 441 443
Material Integrity Problem 388 388
Material Fragmentation 374 374
Corroded 358 364
Mechanics Altered 327 327
Contamination /Decontamination Problem 317 317
Use of Device Problem 222 222
Unintended Movement 222 222
Appropriate Term/Code Not Available 204 204
Entrapment of Device 186 186
Difficult to Open or Close 183 183
Loose or Intermittent Connection 173 173
Difficult to Remove 164 164
Illegible Information 162 162
Dull, Blunt 159 159
Defective Device 156 156
Component Missing 153 153
Compatibility Problem 151 151
No Apparent Adverse Event 134 134
Material Separation 132 132
Connection Problem 122 122
Insufficient Information 111 111
Degraded 103 103
Failure to Align 100 100
Material Discolored 95 95
Failure to Advance 93 93
Device Slipped 87 87
Material Split, Cut or Torn 82 82
Positioning Failure 75 75
Device Dislodged or Dislocated 66 66
Device Contamination with Chemical or Other Material 62 62
Difficult to Advance 62 62
Difficult to Insert 59 59
Flaked 54 54
Unstable 53 53
Manufacturing, Packaging or Shipping Problem 49 49
Fitting Problem 48 48
Improper or Incorrect Procedure or Method 45 45
Device Markings/Labelling Problem 41 41
Peeled/Delaminated 40 40
Deformation Due to Compressive Stress 38 49
Separation Failure 38 38
Device Damaged by Another Device 37 37
Difficult or Delayed Separation 37 37
Device Damaged Prior to Use 36 36
Device Difficult to Setup or Prepare 35 35
Positioning Problem 34 34
Structural Problem 31 31
Device Contaminated During Manufacture or Shipping 29 29
Material Disintegration 29 29
Failure to Cut 28 28
Solder Joint Fracture 28 28
Patient Device Interaction Problem 27 27
Loosening of Implant Not Related to Bone-Ingrowth 27 27
Device Fell 23 23
Activation, Positioning or Separation Problem 23 23
Display Difficult to Read 22 22
Incorrect Measurement 22 22
Difficult or Delayed Positioning 21 21
Incomplete or Inadequate Connection 21 21
Migration 21 21
Migration or Expulsion of Device 20 20
Residue After Decontamination 18 18
Defective Component 18 18
Failure to Clean Adequately 18 18
Device Difficult to Maintain 17 17
Failure to Eject 17 43
Problem with Sterilization 17 17
Delivered as Unsterile Product 17 17
Off-Label Use 16 16
Output Problem 16 16
Product Quality Problem 15 15
Material Frayed 14 14
Malposition of Device 13 13
Packaging Problem 13 13
Inadequacy of Device Shape and/or Size 12 12
Nonstandard Device 11 11
Human-Device Interface Problem 11 11
Failure to Disconnect 11 11
Optical Problem 11 11
Inaccurate Information 11 11
Separation Problem 11 11
Noise, Audible 10 10
Device Handling Problem 10 10
Material Protrusion/Extrusion 10 10
Patient-Device Incompatibility 10 10
Component or Accessory Incompatibility 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16741 16873
No Consequences Or Impact To Patient 5512 5526
No Known Impact Or Consequence To Patient 1586 1586
Insufficient Information 1513 1515
Foreign Body In Patient 899 899
No Patient Involvement 766 766
No Code Available 594 594
Not Applicable 331 331
Device Embedded In Tissue or Plaque 275 275
No Information 160 160
Bone Fracture(s) 138 138
Failure of Implant 116 116
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 110 110
Injury 106 106
Pain 93 93
Unspecified Infection 72 72
Unspecified Tissue Injury 57 57
Tissue Damage 39 39
Loss of Range of Motion 31 31
Nerve Damage 26 26
Laceration(s) 25 25
Joint Dislocation 25 25
Non-union Bone Fracture 21 21
Spinal Column Injury 20 20
Hemorrhage/Bleeding 20 20
Perforation 18 18
Inflammation 17 17
Swelling/ Edema 15 15
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
Burn(s) 8 8
Hypersensitivity/Allergic reaction 8 8
Perforation of Vessels 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
Scar Tissue 6 6
Paralysis 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
Unspecified Musculoskeletal problem 3 3
External Prosthetic Device Pain 2 2
Malunion of Bone 2 2
Hyperextension 2 2
Neuralgia 2 2
Paresthesia 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
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

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