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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 4767 4772
2021 4833 4884
2022 4845 4913
2023 5182 5195
2024 5872 5872

Device Problems MDRs with this Device Problem Events in those MDRs
Break 11630 11630
Device-Device Incompatibility 4406 4406
Fracture 3245 3276
Material Deformation 1613 1651
Naturally Worn 1424 1424
Material Twisted/Bent 1406 1406
Detachment of Device or Device Component 1321 1321
Crack 967 967
Mechanical Jam 849 895
Physical Resistance/Sticking 634 634
Mechanical Problem 621 621
Scratched Material 617 617
Calibration Problem 579 579
Adverse Event Without Identified Device or Use Problem 458 460
Mechanics Altered 438 438
Material Integrity Problem 423 423
Material Fragmentation 389 389
Corroded 372 378
Contamination /Decontamination Problem 343 343
Use of Device Problem 253 253
Unintended Movement 242 242
Appropriate Term/Code Not Available 218 218
Difficult to Open or Close 217 217
Entrapment of Device 191 191
Loose or Intermittent Connection 173 173
Illegible Information 171 171
Compatibility Problem 169 169
Defective Device 169 169
Dull, Blunt 167 167
Difficult to Remove 166 166
No Apparent Adverse Event 159 159
Component Missing 154 154
Material Separation 140 140
Connection Problem 124 124
Insufficient Information 114 114
Degraded 109 109
Failure to Align 102 102
Failure to Advance 100 100
Material Discolored 97 97
Device Slipped 93 93
Positioning Failure 84 84
Material Split, Cut or Torn 84 84
Device Dislodged or Dislocated 69 69
Difficult to Advance 68 68
Device Contamination with Chemical or Other Material 63 63
Difficult to Insert 62 62
Unstable 59 59
Flaked 58 58
Fitting Problem 53 53
Manufacturing, Packaging or Shipping Problem 50 50

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 18607 18739
No Consequences Or Impact To Patient 5513 5527
Insufficient Information 1968 1970
No Known Impact Or Consequence To Patient 1586 1586
Foreign Body In Patient 975 975
No Patient Involvement 766 766
No Code Available 594 594
Not Applicable 331 331
Device Embedded In Tissue or Plaque 278 278
No Information 160 160
Bone Fracture(s) 141 141
Failure of Implant 118 118
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 115 115
Injury 106 106
Pain 96 96
Unspecified Infection 75 75
Unspecified Tissue Injury 59 59
Tissue Damage 39 39
Loss of Range of Motion 31 31
Laceration(s) 26 26
Nerve Damage 26 26
Joint Dislocation 25 25
Non-union Bone Fracture 21 21
Spinal Column Injury 20 20
Hemorrhage/Bleeding 20 20
Perforation 19 19
Inflammation 17 17
Swelling/ Edema 16 16
Muscle/Tendon Damage 14 14
Limb Fracture 13 13
Subluxation 12 12
Ambulation Difficulties 12 12
Post Operative Wound Infection 11 11
Patient Problem/Medical Problem 11 11
Fluid Discharge 10 10
Hypersensitivity/Allergic reaction 10 10
Rheumatoid Arthritis 10 10
Implant Pain 9 9
Joint Laxity 9 9
Blood Loss 9 9
Bacterial Infection 8 8
Burn(s) 8 8
Rupture 8 8
Discomfort 8 8
Arthralgia 7 7
Hip Fracture 7 7
Perforation of Vessels 7 7
Muscular Rigidity 6 6
Weakness 6 6
Spinal Cord Injury 6 6

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