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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
2021 4832 4897
2022 4843 4950
2023 5163 5229
2024 6319 6344
2025 6195 6335
2026 1947 1948

Device Problems MDRs with this Device Problem Events in those MDRs
Break 10904 10967
Device-Device Incompatibility 4336 4352
Fracture 3473 3545
Material Deformation 2153 2197
Detachment of Device or Device Component 1279 1283
Naturally Worn 1171 1176
Mechanics Altered 1069 1069
Material Twisted/Bent 816 818
Physical Resistance/Sticking 711 711
Mechanical Jam 706 747
Crack 634 639
Mechanical Problem 496 496
Calibration Problem 495 496
Material Fragmentation 481 571
Material Integrity Problem 439 440
Contamination /Decontamination Problem 416 422
Adverse Event Without Identified Device or Use Problem 335 375
Use of Device Problem 332 336
Difficult to Open or Close 289 289
Corroded 269 277
Unintended Movement 254 254
No Apparent Adverse Event 246 246
Compatibility Problem 173 173
Entrapment of Device 150 151
Defective Device 144 145
Dull, Blunt 141 141
Optical Problem 138 138
Appropriate Term/Code Not Available 135 135
Material Separation 118 118
Scratched Material 110 110
Failure to Align 108 109
Degraded 105 105
Failure to Advance 101 101
Positioning Failure 99 99
Material Split, Cut or Torn 97 97
Device Slipped 92 92
Loose or Intermittent Connection 88 89
Difficult to Remove 75 75
Difficult to Advance 75 75
Insufficient Information 75 77
Unstable 66 66
Difficult to Insert 63 63
Illegible Information 63 63
Connection Problem 60 60
Device Damaged by Another Device 59 59
Manufacturing, Packaging or Shipping Problem 55 55
Improper or Incorrect Procedure or Method 53 53
Flaked 53 53
Device Dislodged or Dislocated 52 57
Device Difficult to Setup or Prepare 46 47

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 25214 25553
Insufficient Information 2591 2606
Foreign Body In Patient 1049 1057
Device Embedded In Tissue or Plaque 127 127
Failure of Implant 108 111
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 103 104
Pain 82 89
Bone Fracture(s) 82 85
Unspecified Tissue Injury 53 53
Unspecified Infection 46 75
Perforation 33 35
Laceration(s) 29 31
Spinal Column Injury 27 27
Hemorrhage/Bleeding 24 24
Loss of Range of Motion 24 28
No Consequences Or Impact To Patient 22 22
Nerve Damage 21 21
Swelling/ Edema 19 19
Non-union Bone Fracture 16 19
Muscle/Tendon Damage 16 19
Implant Pain 16 16
Perforation of Vessels 14 14
Limb Fracture 14 14
Joint Dislocation 13 16
Ambulation Difficulties 12 12
Hypersensitivity/Allergic reaction 9 9
Post Operative Wound Infection 9 9
Bacterial Infection 8 8
Foreign Body Reaction 8 8
Impaired Healing 7 7
No Known Impact Or Consequence To Patient 7 7
Osteopenia/ Osteoporosis 7 7
Numbness 7 7
Joint Laxity 6 7
Necrosis 6 6
Scar Tissue 6 6
Discomfort 6 6
Rupture 6 8
Burn(s) 5 5
Osteolysis 5 5
Inflammation 5 5
No Information 5 5
Fluid Discharge 5 5
Cerebrospinal Fluid Leakage 5 5
Abrasion 4 4
No Patient Involvement 4 4
Hematoma 4 6
Exsanguination 4 4
Unspecified Musculoskeletal problem 4 4
Cardiac Arrest 4 4

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 ConMed Corporation II Apr-27-2021
7 DePuy Mitek, Inc., a Johnson & Johnson Co. II Mar-11-2025
8 Gauthier Biomedical, Inc. II Nov-27-2024
9 Howmedica Osteonics Corp. II Jun-18-2024
10 Howmedica Osteonics Corp. II Feb-06-2024
11 Howmedica Osteonics Corp. II Jun-14-2023
12 In2bones USA, LLC II Sep-22-2021
13 Integrity Implants Inc. II Jan-22-2025
14 Intrinsic Therapeutics, Inc. II Aug-20-2024
15 Laboratoires Bodycad, Inc. II Nov-17-2021
16 Medacta Usa Inc II Jun-07-2022
17 Medtronic Sofamor Danek USA Inc II May-10-2023
18 Mizuho OSI II Aug-24-2022
19 ORTHOPEDIATRICS CANADA ULC Dba PEGA MEDICAL II Aug-29-2024
20 SONEX HEALTH LLC II Jul-15-2022
21 Spineology, Inc. II Oct-17-2024
22 Stryker GmbH II Apr-17-2025
23 Stryker Spine II Dec-21-2023
24 Synthes (USA) Products LLC II Feb-10-2022
25 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Jul-03-2023
26 Tornier, Inc II Jun-01-2022
27 Waldemar Link GmbH & Co. KG (Corp. Hq.) II Sep-24-2024
28 Waldemar Link GmbH & Co. KG (Mfg Site) II Aug-29-2023
29 restor3d Inc. II Apr-29-2022
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