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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
KOROS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOVITA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SONEX HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 3843 3843
2015 5947 5947
2016 6359 6359
2017 4132 4132
2018 4685 4685
2019 5224 5233
2020 4766 4771
2021 4833 4884
2022 4844 4912
2023 5182 5195
2024 1395 1395

Device Problems MDRs with this Device Problem Events in those MDRs
Break 23331 23331
Fracture 4376 4407
Device-Device Incompatibility 4073 4073
Appropriate Term/Code Not Available 2213 2213
Crack 1868 1868
Material Deformation 1704 1742
Detachment of Device or Device Component 1521 1521
Naturally Worn 1485 1485
Material Twisted/Bent 1377 1377
Mechanical Jam 1293 1339
Mechanical Problem 909 909
Device Operates Differently Than Expected 890 890
Material Integrity Problem 871 871
Scratched Material 867 867
Material Fragmentation 705 705
Adverse Event Without Identified Device or Use Problem 675 677
Detachment Of Device Component 656 656
Corroded 599 605
Component Missing 595 595
Dull, Blunt 594 594
Calibration Problem 524 524
Difficult to Remove 524 524
Insufficient Information 512 512
Bent 482 482
Physical Resistance/Sticking 366 366
Loose or Intermittent Connection 344 344
Failure to Align 329 329
Contamination /Decontamination Problem 324 324
Mechanics Altered 310 310
Fitting Problem 309 309
Use of Device Problem 267 267
Entrapment of Device 253 253
Unintended Movement 235 235
Connection Problem 230 230
Sticking 202 202
Device Contamination with Chemical or Other Material 190 190
Device Slipped 187 187
Difficult to Open or Close 181 181
Material Separation 180 180
Tip breakage 179 179
Illegible Information 168 168
Disassembly 163 163
Compatibility Problem 161 161
Degraded 155 155
Difficult to Insert 154 154
Material Discolored 153 153
Defective Device 142 142
Positioning Problem 137 137
Device Dislodged or Dislocated 130 130
Separation Failure 121 121
No Apparent Adverse Event 121 121
Failure to Advance 109 109
Improper or Incorrect Procedure or Method 100 100
Failure To Adhere Or Bond 99 99
Device Reprocessing Problem 93 93
Positioning Failure 85 85
Component Falling 85 85
Metal Shedding Debris 84 84
Manufacturing, Packaging or Shipping Problem 78 78
Material Split, Cut or Torn 77 77
Peeled/Delaminated 74 74
Flaked 70 70
Device Inoperable 68 68
Device Or Device Fragments Location Unknown 68 68
Difficult to Advance 63 63
Device Damaged by Another Device 62 62
Malposition of Device 62 62
Device Damaged Prior to Use 61 61
Unstable 61 61
Deformation Due to Compressive Stress 53 64
Failure to Disconnect 53 53
Device Markings/Labelling Problem 53 53
Migration or Expulsion of Device 51 51
Nonstandard Device 48 48
Residue After Decontamination 45 45
Defective Component 44 44
Material Disintegration 40 40
Difficult To Position 39 39
Device Difficult to Setup or Prepare 39 39
Device Issue 38 38
Incorrect Measurement 38 38
Failure to Cut 37 37
Difficult or Delayed Separation 36 36
Packaging Problem 36 36
Misconnection 34 34
Device Contaminated During Manufacture or Shipping 33 33
Structural Problem 32 32
Solder Joint Fracture 32 32
Patient Device Interaction Problem 31 31
Device Fell 30 30
Device Operational Issue 30 30
Inadequacy of Device Shape and/or Size 30 30
Disconnection 28 28
Activation, Positioning or Separation Problem 27 27
Noise, Audible 27 27
Device Handling Problem 26 26
Difficult or Delayed Positioning 25 25
Problem with Sterilization 25 25
Loosening of Implant Not Related to Bone-Ingrowth 24 24
Incomplete or Inadequate Connection 23 23

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 15040 15172
No Known Impact Or Consequence To Patient 11193 11193
No Consequences Or Impact To Patient 10270 10285
No Information 7540 7540
No Patient Involvement 1835 1835
No Code Available 1401 1401
Foreign Body In Patient 1325 1325
Insufficient Information 1139 1141
Device Embedded In Tissue or Plaque 1087 1087
Not Applicable 505 505
Bone Fracture(s) 322 322
Injury 224 224
Pain 166 166
Unspecified Infection 165 165
Sedation 154 154
Failure of Implant 138 138
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 106 106
Tissue Damage 89 89
Unknown (for use when the patient's condition is not known) 56 56
Unspecified Tissue Injury 53 53
Laceration(s) 36 36
Loss of Range of Motion 32 32
Blood Loss 32 32
Non-union Bone Fracture 31 31
Hemorrhage/Bleeding 30 30
Joint Dislocation 29 29
Nerve Damage 28 28
Perforation 21 21
Hip Fracture 20 20
Discomfort 19 19
Spinal Column Injury 19 19
Inflammation 19 19
Death 19 19
Ambulation Difficulties 17 17
Patient Problem/Medical Problem 17 17
Post Operative Wound Infection 16 16
Paralysis 16 16
Perforation of Vessels 15 15
Swelling/ Edema 15 15
Muscle/Tendon Damage 14 14
Pulmonary Embolism 14 14
Bacterial Infection 14 14
Foreign Body Reaction 13 13
Swelling 13 13
Complaint, Ill-Defined 13 13
Joint Disorder 12 12
Hematoma 12 12
Burn(s) 12 12
Limb Fracture 12 12
Subluxation 11 11
Surgical procedure, delayed 11 11
Fluid Discharge 10 10
Rheumatoid Arthritis 10 10
Rupture 10 10
Weakness 9 9
Osteolysis 9 9
Reaction 9 9
Numbness 9 9
Hypersensitivity/Allergic reaction 9 9
Joint Laxity 9 9
Implant Pain 8 8
Fall 8 8
Impaired Healing 8 8
Scar Tissue 8 8
Necrosis 7 7
Arthralgia 7 7
Spinal Cord Injury 7 7
Muscle Weakness 6 6
Muscular Rigidity 6 6
Occlusion 6 6
Debris, Bone Shedding 6 6
Cerebrospinal Fluid Leakage 6 6
Cardiac Arrest 5 5
Foreign body, removal of 5 5
Surgical procedure, repeated 5 5
Neurological Deficit/Dysfunction 5 5
Neuropathy 5 5
Synovitis 5 5
Osteopenia/ Osteoporosis 5 5
Disc Impingement 5 5
Limited Mobility Of The Implanted Joint 5 5
Inadequate Osseointegration 4 4
Local Reaction 4 4
Deformity/ Disfigurement 4 4
Great Vessel Perforation 4 4
Arthritis 4 4
Abscess 4 4
Vessel Or Plaque, Device Embedded In 4 4
Purulent Discharge 4 4
Erythema 4 4
Damage to Ligament(s) 4 4
Irritation 3 3
Infiltration into Tissue 3 3
Myocardial Infarction 3 3
Fever 3 3
Headache 3 3
Bruise/Contusion 3 3
Connective Tissue Disease 3 3
Host-Tissue Reaction 3 3
Adhesion(s) 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Acumed LLC II Dec-26-2023
2 Acumed LLC II Mar-16-2017
3 Ad-Tech Medical Instrument Corporation II May-25-2018
4 Aesculap Implant Systems LLC II Jul-21-2022
5 Aesculap Implant Systems LLC II Jul-21-2022
6 Aesculap Implant Systems LLC II Jul-15-2022
7 Aesculap, Inc. II Nov-19-2013
8 Aesculap, Inc. II Oct-18-2012
9 Amendia, Inc II Apr-25-2017
10 Amendia, Inc II Dec-22-2016
11 Arthrex, Inc. II May-05-2022
12 Arthrex, Inc. II Jan-30-2020
13 ArthroCare Medical Corporation II Jan-09-2014
14 Bacterin International, Inc. II Apr-07-2015
15 Biomet II Jun-12-2020
16 Biomet Microfixation, Inc. II Aug-01-2011
17 Biomet Microfixation, Inc. II Nov-10-2009
18 Biomet U.K., Ltd. II Feb-22-2017
19 Biomet U.K., Ltd. II Mar-19-2012
20 Biomet, Inc. II May-26-2016
21 Biomet, Inc. II Feb-25-2016
22 Biomet, Inc. II Jun-16-2014
23 Biomet, Inc. II Mar-20-2014
24 Biomet, Inc. II Jun-15-2013
25 Biomet, Inc. II Mar-08-2013
26 Biomet, Inc. II Sep-30-2011
27 Biomet, Inc. II Jun-30-2011
28 Biomet, Inc. II Dec-28-2010
29 Biomet, Inc. II Sep-28-2010
30 Biomet, Inc. II Sep-25-2010
31 Biomet, Inc. II Jan-15-2010
32 Biomet, Inc. II Jun-01-2009
33 Biomet, Inc. II Jan-07-2009
34 Captiva Spine, Inc II Apr-21-2015
35 Cardinal Health 200, LLC II Oct-11-2016
36 ConMed Corporation II Apr-27-2021
37 ConMed Corporation II Dec-21-2020
38 DePuy Mitek, Inc., a Johnson & Johnson Co. II Oct-23-2018
39 DePuy Mitek, Inc., a Johnson & Johnson Co. II May-08-2018
40 DePuy Mitek, Inc., a Johnson & Johnson Co. II Aug-31-2011
41 DePuy Orthopaedics, Inc. II Apr-11-2019
42 DePuy Orthopaedics, Inc. II Mar-02-2018
43 DePuy Orthopaedics, Inc. II Jun-08-2017
44 DePuy Orthopaedics, Inc. II Oct-07-2015
45 DePuy Orthopaedics, Inc. II Mar-31-2015
46 DePuy Orthopaedics, Inc. II Jan-12-2015
47 DePuy Orthopaedics, Inc. II Jan-05-2015
48 DePuy Orthopaedics, Inc. II Jan-05-2015
49 DePuy Orthopaedics, Inc. II Nov-10-2014
50 DePuy Orthopaedics, Inc. II Oct-08-2014
51 DePuy Orthopaedics, Inc. II Nov-27-2013
52 DePuy Orthopaedics, Inc. II Mar-19-2013
53 DePuy Orthopaedics, Inc. II Apr-16-2012
54 DePuy Orthopaedics, Inc. II Apr-16-2012
55 Depuy Orthopaedics, Inc. II Mar-22-2011
56 Depuy Orthopaedics, Inc. II Feb-22-2011
57 Depuy Orthopaedics, Inc. II Oct-06-2010
58 Ebi, Llc II Sep-17-2013
59 Encore Medical, Lp II Dec-06-2019
60 Encore Medical, Lp II Nov-02-2011
61 Encore Medical, Lp II Sep-30-2010
62 Encore Medical, Lp II Aug-02-2010
63 Exactech, Inc. II Oct-11-2018
64 Exactech, Inc. II Jun-19-2017
65 Exactech, Inc. II Jun-19-2017
66 Flower Orthopedics Corporation II Jan-28-2017
67 Greatbatch Medical II Feb-11-2017
68 Greatbatch Medical II Jan-30-2013
69 Howmedica Osteonics Corp. II Feb-06-2024
70 Howmedica Osteonics Corp. II Jun-14-2023
71 Howmedica Osteonics Corp. II Dec-21-2018
72 Howmedica Osteonics Corp. II Nov-02-2018
73 Howmedica Osteonics Corp. II Oct-23-2018
74 Howmedica Osteonics Corp. II Mar-01-2018
75 Implant Direct Sybron Manufacturing, LLC II Sep-11-2017
76 In2bones USA, LLC II Sep-22-2021
77 Integra LifeSciences Corp. II Jan-23-2009
78 K2M, Inc II Dec-07-2020
79 LDR Spine USA, Inc. II Oct-05-2016
80 Laboratoires Bodycad, Inc. II Nov-17-2021
81 Limacorporate S.p.A II Nov-06-2017
82 Limacorporate S.p.A II Aug-31-2016
83 Linvatec Corp. dba ConMed Linvatec II Feb-05-2013
84 Linvatec Corp. dba ConMed Linvatec II Oct-29-2012
85 Linvatec Corp. dba ConMed Linvatec II Aug-06-2012
86 Linvatec Corp. dba ConMed Linvatec II Aug-06-2012
87 Linvatec Corp. dba ConMed Linvatec II Aug-24-2010
88 MEDLINE INDUSTRIES INC II May-17-2017
89 Medacta Usa Inc II Jun-07-2022
90 Medtronic Sofamor Danek USA Inc II May-10-2023
91 Medtronic Sofamor Danek USA Inc II May-05-2017
92 Medtronic Sofamor Danek USA Inc II Apr-19-2012
93 Medtronic Sofamor Danek USA Inc II Jan-12-2010
94 Microport Orthopedics INC. II Jun-04-2014
95 Mizuho OSI II Aug-24-2022
96 OMNIlife science Inc. II Feb-14-2019
97 Orthohelix Surgical Designs Inc II Oct-10-2014
98 Orthohelix Surgical Designs Inc II Apr-15-2010
99 Pega Medical Inc. III May-15-2020
100 Pega Medical Inc. II Nov-01-2019
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