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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 5184 5197
2024 6331 6331
2025 2906 2906

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10914 10914
Device-Device Incompatibility 4272 4272
Fracture 3221 3252
Material Deformation 1720 1758
Detachment of Device or Device Component 1267 1267
Naturally Worn 1249 1249
Material Twisted/Bent 1060 1060
Mechanics Altered 850 850
Mechanical Jam 733 770
Crack 683 683
Physical Resistance/Sticking 623 623
Calibration Problem 543 543
Mechanical Problem 509 509
Material Integrity Problem 425 425
Contamination /Decontamination Problem 362 362
Adverse Event Without Identified Device or Use Problem 352 354
Scratched Material 312 312
Material Fragmentation 312 312
Use of Device Problem 279 279
Corroded 266 272
Difficult to Open or Close 237 237
Unintended Movement 224 224
No Apparent Adverse Event 197 197
Defective Device 175 175
Compatibility Problem 175 175
Entrapment of Device 169 169
Appropriate Term/Code Not Available 167 167
Illegible Information 160 160
Dull, Blunt 159 159
Material Separation 133 133
Loose or Intermittent Connection 123 123
Degraded 115 115
Optical Problem 106 106
Failure to Align 103 103
Difficult to Remove 100 100
Component Missing 94 94
Failure to Advance 88 88
Connection Problem 87 87
Positioning Failure 86 86
Material Split, Cut or Torn 84 84
Device Slipped 79 79
Insufficient Information 76 76
Difficult to Advance 72 72
Unstable 60 60
Flaked 56 56
Difficult to Insert 55 55
Manufacturing, Packaging or Shipping Problem 53 53
Device Dislodged or Dislocated 52 52
Improper or Incorrect Procedure or Method 46 46
Device Damaged by Another Device 44 44

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 21397 21529
Insufficient Information 2441 2443
No Consequences Or Impact To Patient 2328 2333
Foreign Body In Patient 962 962
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 172 172
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 116 116
Bone Fracture(s) 105 105
Failure of Implant 105 105
Not Applicable 103 103
Injury 77 77
Pain 76 76
Unspecified Tissue Injury 63 63
No Information 50 50
Unspecified Infection 50 50
Laceration(s) 29 29
Joint Dislocation 25 25
Hemorrhage/Bleeding 24 24
Perforation 23 23
Nerve Damage 23 23
Spinal Column Injury 23 23
Loss of Range of Motion 22 22
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
Ambulation Difficulties 10 10
Rheumatoid Arthritis 10 10
Fluid Discharge 10 10
Hypersensitivity/Allergic reaction 9 9
Post Operative Wound Infection 9 9
Joint Laxity 9 9
Implant Pain 9 9
Perforation of Vessels 9 9
Numbness 8 8
Arthralgia 8 8
Patient Problem/Medical Problem 8 8
Burn(s) 8 8
Inflammation 7 7
Bacterial Infection 7 7
Hematoma 6 6
Spinal Cord Injury 6 6
Necrosis 6 6
Scar Tissue 6 6
Rupture 6 6
Cerebrospinal Fluid Leakage 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 Mitek, Inc., a Johnson & Johnson Co. II Mar-11-2025
11 Gauthier Biomedical, Inc. II Nov-27-2024
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 Integrity Implants Inc. II Jan-22-2025
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 ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL II Aug-29-2024
24 Pega Medical Inc. III May-15-2020
25 SONEX HEALTH LLC II Jul-15-2022
26 Smith & Nephew, Inc. II Aug-10-2020
27 Spineology, Inc. II Oct-17-2024
28 Stryker GmbH II Apr-17-2025
29 Stryker Spine II Dec-21-2023
30 Synthes (USA) Products LLC II Feb-10-2022
31 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
32 TeDan Surgical Innovations LLC II Jul-10-2020
33 TeDan Surgical Innovations LLC II Mar-17-2020
34 Tornier, Inc II Jun-01-2022
35 Waldemar Link GmbH & Co. KG (Corp. Hq.) II Sep-24-2024
36 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-29-2023
37 Zimmer Biomet, Inc. II Jun-02-2020
38 Zimmer Biomet, Inc. II Jan-28-2020
39 restor3d Inc. II Apr-29-2022
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