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TPLC
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Device
orthopedic manual surgical instrument
Product Code
LXH
Regulation Number
888.4540
Device Class
1
Premarket Reviews
Manufacturer
Decision
SONEX HEALTH, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
5224
5233
2020
4766
4771
2021
4833
4884
2022
4844
4912
2023
5182
5195
2024
918
918
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
10002
10002
Device-Device Incompatibility
3791
3791
Fracture
2604
2635
Material Deformation
1354
1392
Material Twisted/Bent
1226
1226
Detachment of Device or Device Component
1206
1206
Naturally Worn
988
988
Crack
892
892
Mechanical Jam
729
775
Scratched Material
610
610
Mechanical Problem
569
569
Calibration Problem
490
490
Adverse Event Without Identified Device or Use Problem
426
428
Material Integrity Problem
374
374
Material Fragmentation
345
345
Physical Resistance/Sticking
326
326
Corroded
295
301
Contamination /Decontamination Problem
293
293
Mechanics Altered
260
260
Unintended Movement
201
201
Appropriate Term/Code Not Available
199
199
Use of Device Problem
193
193
Entrapment of Device
176
176
Loose or Intermittent Connection
167
167
Difficult to Remove
163
163
Illegible Information
156
156
Component Missing
150
150
Difficult to Open or Close
150
150
Compatibility Problem
147
147
Connection Problem
118
118
Dull, Blunt
110
110
Insufficient Information
102
102
Degraded
100
100
Defective Device
98
98
Material Separation
97
97
Failure to Align
89
89
Material Discolored
86
86
No Apparent Adverse Event
86
86
Device Slipped
85
85
Positioning Failure
67
67
Material Split, Cut or Torn
67
67
Device Contamination with Chemical or Other Material
61
61
Difficult to Insert
57
57
Flaked
54
54
Failure to Advance
53
53
Manufacturing, Packaging or Shipping Problem
48
48
Device Dislodged or Dislocated
48
48
Difficult to Advance
47
47
Improper or Incorrect Procedure or Method
44
44
Unstable
38
38
Deformation Due to Compressive Stress
36
47
Device Damaged Prior to Use
35
35
Difficult or Delayed Separation
35
35
Positioning Problem
33
33
Separation Failure
33
33
Device Difficult to Setup or Prepare
32
32
Peeled/Delaminated
30
30
Fitting Problem
30
30
Device Damaged by Another Device
29
29
Material Disintegration
29
29
Solder Joint Fracture
28
28
Structural Problem
28
28
Device Markings/Labelling Problem
27
27
Device Contaminated During Manufacture or Shipping
26
26
Patient Device Interaction Problem
26
26
Failure to Cut
25
25
Activation, Positioning or Separation Problem
23
23
Device Fell
23
23
Loosening of Implant Not Related to Bone-Ingrowth
22
22
Display Difficult to Read
22
22
Difficult or Delayed Positioning
21
21
Incorrect Measurement
21
21
Incomplete or Inadequate Connection
21
21
Migration
20
20
Migration or Expulsion of Device
20
20
Defective Component
17
17
Device Difficult to Maintain
17
17
Failure to Clean Adequately
17
17
Failure to Eject
17
43
Residue After Decontamination
16
16
Off-Label Use
16
16
Problem with Sterilization
15
15
Delivered as Unsterile Product
15
15
Output Problem
15
15
Packaging Problem
12
12
Inadequacy of Device Shape and/or Size
12
12
Malposition of Device
12
12
Failure to Disconnect
11
11
Nonstandard Device
11
11
Product Quality Problem
11
11
Patient-Device Incompatibility
10
10
Human-Device Interface Problem
10
10
Material Protrusion/Extrusion
10
10
Noise, Audible
10
10
Inaccurate Information
10
10
Device Handling Problem
9
9
Component Misassembled
9
9
Component or Accessory Incompatibility
9
9
Loss of Osseointegration
9
9
Unsealed Device Packaging
8
8
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
14658
14790
No Consequences Or Impact To Patient
5512
5526
No Known Impact Or Consequence To Patient
1586
1586
Insufficient Information
1058
1060
Foreign Body In Patient
835
835
No Patient Involvement
766
766
No Code Available
594
594
Not Applicable
331
331
Device Embedded In Tissue or Plaque
273
273
No Information
160
160
Bone Fracture(s)
130
130
Injury
106
106
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
106
106
Failure of Implant
90
90
Pain
88
88
Unspecified Infection
70
70
Unspecified Tissue Injury
53
53
Tissue Damage
39
39
Loss of Range of Motion
30
30
Nerve Damage
26
26
Laceration(s)
25
25
Joint Dislocation
23
23
Non-union Bone Fracture
20
20
Hemorrhage/Bleeding
19
19
Inflammation
17
17
Perforation
15
15
Swelling/ Edema
15
15
Muscle/Tendon Damage
14
14
Limb Fracture
12
12
Subluxation
11
11
Patient Problem/Medical Problem
11
11
Post Operative Wound Infection
11
11
Fluid Discharge
10
10
Rheumatoid Arthritis
10
10
Joint Laxity
9
9
Ambulation Difficulties
9
9
Blood Loss
9
9
Rupture
8
8
Implant Pain
8
8
Bacterial Infection
8
8
Hypersensitivity/Allergic reaction
8
8
Spinal Column Injury
8
8
Burn(s)
7
7
Hip Fracture
7
7
Discomfort
7
7
Arthralgia
7
7
Osteolysis
6
6
Weakness
6
6
Numbness
6
6
Spinal Cord Injury
6
6
Scar Tissue
6
6
Perforation of Vessels
6
6
Paralysis
6
6
Hematoma
6
6
Muscular Rigidity
6
6
Neurological Deficit/Dysfunction
5
5
Necrosis
5
5
Disc Impingement
5
5
Impaired Healing
5
5
Reaction
5
5
Deformity/ Disfigurement
4
4
Limited Mobility Of The Implanted Joint
4
4
Inadequate Osseointegration
4
4
Osteopenia/ Osteoporosis
4
4
Fall
4
4
Foreign Body Reaction
4
4
Connective Tissue Disease
3
3
Purulent Discharge
3
3
Vessel Or Plaque, Device Embedded In
3
3
Abscess
3
3
Adhesion(s)
3
3
Neuropathy
3
3
Myocardial Infarction
3
3
Damage to Ligament(s)
3
3
Muscle Weakness
3
3
Infiltration into Tissue
3
3
Irritation
2
2
Headache
2
2
Internal Organ Perforation
2
2
Overdose
2
2
Rash
2
2
Swelling
2
2
Synovitis
2
2
Thrombosis
2
2
Pulmonary Embolism
2
2
Wound Dehiscence
2
2
Cardiac Arrest
2
2
Cellulitis
2
2
Cerebrospinal Fluid Leakage
2
2
Dysphagia/ Odynophagia
2
2
Exsanguination
2
2
Intraoperative Pain
2
2
Paraplegia
2
2
Quadriplegia
2
2
Needle Stick/Puncture
2
2
Great Vessel Perforation
2
2
Seroma
2
2
Neuralgia
2
2
Paresthesia
2
2
External Prosthetic Device Pain
2
2
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
Howmedica Osteonics Corp.
II
Feb-06-2024
13
Howmedica Osteonics Corp.
II
Jun-14-2023
14
In2bones USA, LLC
II
Sep-22-2021
15
K2M, Inc
II
Dec-07-2020
16
Laboratoires Bodycad, Inc.
II
Nov-17-2021
17
Medacta Usa Inc
II
Jun-07-2022
18
Medtronic Sofamor Danek USA Inc
II
May-10-2023
19
Mizuho OSI
II
Aug-24-2022
20
OMNIlife science Inc.
II
Feb-14-2019
21
Pega Medical Inc.
III
May-15-2020
22
Pega Medical Inc.
II
Nov-01-2019
23
SONEX HEALTH LLC
II
Jul-15-2022
24
Smith & Nephew, Inc.
II
Aug-10-2020
25
Smith & Nephew, Inc.
II
Nov-08-2019
26
Smith & Nephew, Inc.
II
Jan-12-2019
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
TriMed Inc.
II
Nov-12-2019
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
Zimmer Biomet, Inc.
II
Dec-03-2019
38
Zimmer Biomet, Inc.
II
Nov-22-2019
39
Zimmer Biomet, Inc.
II
Nov-07-2019
40
Zimmer Biomet, Inc.
II
Jul-04-2019
41
Zimmer Biomet, Inc.
II
Jun-19-2019
42
Zimmer Biomet, Inc.
II
Jun-06-2019
43
restor3d Inc.
II
Apr-29-2022
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