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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
Regulation Description Orthopedic manual surgical instrument.
Product CodeLXH
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 4766 4771
2021 4833 4884
2022 4845 4913
2023 5182 5195
2024 6330 6330
2025 502 502

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10094 10094
Device-Device Incompatibility 4001 4001
Fracture 2942 2973
Material Deformation 1477 1515
Naturally Worn 1234 1234
Detachment of Device or Device Component 1230 1230
Material Twisted/Bent 998 998
Mechanical Jam 684 721
Crack 645 645
Physical Resistance/Sticking 543 543
Calibration Problem 513 513
Mechanical Problem 483 483
Mechanics Altered 475 475
Material Integrity Problem 405 405
Adverse Event Without Identified Device or Use Problem 336 338
Contamination /Decontamination Problem 314 314
Material Fragmentation 304 304
Scratched Material 302 302
Use of Device Problem 246 246
Corroded 220 226
Difficult to Open or Close 208 208
Unintended Movement 208 208
Compatibility Problem 169 169
No Apparent Adverse Event 167 167
Defective Device 166 166
Entrapment of Device 163 163
Illegible Information 159 159
Dull, Blunt 150 150
Appropriate Term/Code Not Available 147 147
Material Separation 128 128
Loose or Intermittent Connection 117 117
Degraded 105 105
Difficult to Remove 97 97
Failure to Align 93 93
Component Missing 92 92
Failure to Advance 86 86
Connection Problem 86 86
Material Split, Cut or Torn 78 78
Device Slipped 76 76
Insufficient Information 73 73
Positioning Failure 67 67
Difficult to Advance 66 66
Unstable 57 57
Flaked 56 56
Device Dislodged or Dislocated 49 49
Manufacturing, Packaging or Shipping Problem 48 48
Difficult to Insert 46 46
Improper or Incorrect Procedure or Method 44 44
Difficult or Delayed Separation 38 38
Device Damaged by Another Device 36 36

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 19366 19498
No Consequences Or Impact To Patient 2328 2333
Insufficient Information 2118 2120
Foreign Body In Patient 902 902
No Known Impact Or Consequence To Patient 752 752
No Patient Involvement 429 429
No Code Available 367 367
Device Embedded In Tissue or Plaque 164 164
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 115 115
Bone Fracture(s) 103 103
Not Applicable 103 103
Failure of Implant 99 99
Injury 77 77
Pain 71 71
Unspecified Tissue Injury 59 59
Unspecified Infection 50 50
No Information 50 50
Laceration(s) 27 27
Joint Dislocation 25 25
Nerve Damage 23 23
Hemorrhage/Bleeding 22 22
Loss of Range of Motion 22 22
Spinal Column Injury 20 20
Perforation 19 19
Swelling/ Edema 16 16
Muscle/Tendon Damage 16 16
Tissue Damage 14 14
Non-union Bone Fracture 13 13
Limb Fracture 13 13
Subluxation 12 12
Fluid Discharge 10 10
Rheumatoid Arthritis 10 10
Hypersensitivity/Allergic reaction 9 9
Implant Pain 9 9
Joint Laxity 9 9
Ambulation Difficulties 9 9
Arthralgia 8 8
Perforation of Vessels 8 8
Post Operative Wound Infection 8 8
Patient Problem/Medical Problem 8 8
Numbness 8 8
Burn(s) 8 8
Inflammation 7 7
Bacterial Infection 7 7
Necrosis 6 6
Rupture 6 6
Hematoma 6 6
Scar Tissue 6 6
Spinal Cord Injury 6 6
Neurological Deficit/Dysfunction 5 5

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 Gauthier Biomedical, Inc. II Nov-27-2024
11 Howmedica Osteonics Corp. II Jun-18-2024
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 Integrity Implants Inc. II Jan-22-2025
16 Intrinsic Therapeutics, Inc. II Aug-20-2024
17 K2M, Inc II Dec-07-2020
18 Laboratoires Bodycad, Inc. II Nov-17-2021
19 Medacta Usa Inc II Jun-07-2022
20 Medtronic Sofamor Danek USA Inc II May-10-2023
21 Mizuho OSI II Aug-24-2022
22 ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL II Aug-29-2024
23 Pega Medical Inc. III May-15-2020
24 SONEX HEALTH LLC II Jul-15-2022
25 Smith & Nephew, Inc. II Aug-10-2020
26 Spineology, Inc. II Oct-17-2024
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 Waldemar Link GmbH & Co. KG (Corp. Hq.) II Sep-24-2024
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 restor3d Inc. II Apr-29-2022
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