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TPLC
New Search
show TPLC since
2009
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2024
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Device
pin, fixation, threaded
Product Code
JDW
Regulation Number
888.3040
Device Class
2
Premarket Reviews
Manufacturer
Decision
AAP IMPLANTATE AG
SUBSTANTIALLY EQUIVALENT
1
ACUMED LLC
SUBSTANTIALLY EQUIVALENT
1
BIOPRO, INC.
SUBSTANTIALLY EQUIVALENT
1
CITIEFFE S.R.L
SUBSTANTIALLY EQUIVALENT
1
DEPUY ORTHOPAEDICS, INC.
SUBSTANTIALLY EQUIVALENT
1
EISERTECH, LLC
SUBSTANTIALLY EQUIVALENT
1
GENOSSIS, LLC
SUBSTANTIALLY EQUIVALENT
1
MERETE MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
2
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
4
STRYKER GMBH
SUBSTANTIALLY EQUIVALENT
1
SUMMIT MEDVENTURES
SUBSTANTIALLY EQUIVALENT
1
SYNTEC SCIENTIFIC CORPORATION
SUBSTANTIALLY EQUIVALENT
1
TINAVI (ANHUI) MEDICAL TECHNOLOGIES CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
VILEX IN TENNESSEE, INC
SUBSTANTIALLY EQUIVALENT
1
VILEX, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
26
26
2015
70
70
2016
46
46
2017
43
43
2018
94
94
2019
575
575
2020
402
402
2021
168
168
2022
124
124
2023
74
74
2024
56
56
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
912
912
Break
186
186
Fracture
94
94
Insufficient Information
91
91
Mechanical Problem
84
84
Patient Device Interaction Problem
66
66
Migration
44
44
Material Fragmentation
27
27
Device Markings/Labelling Problem
24
24
Material Deformation
20
20
Appropriate Term/Code Not Available
19
19
Loose or Intermittent Connection
17
17
Patient-Device Incompatibility
16
16
Detachment Of Device Component
15
15
Malposition of Device
14
14
Device Dislodged or Dislocated
14
14
Device-Device Incompatibility
12
12
Loosening of Implant Not Related to Bone-Ingrowth
11
11
Mechanical Jam
11
11
Dull, Blunt
9
9
Bent
9
9
Unintended Movement
9
9
Entrapment of Device
8
8
Detachment of Device or Device Component
8
8
Inadequacy of Device Shape and/or Size
8
8
Crack
6
6
Difficult to Remove
5
5
Naturally Worn
5
5
Device Operates Differently Than Expected
5
5
Device Slipped
5
5
Physical Resistance/Sticking
4
4
Defective Component
4
4
Packaging Problem
4
4
Product Quality Problem
4
4
Contamination
4
4
Device Contaminated During Manufacture or Shipping
3
3
Material Split, Cut or Torn
3
3
Manufacturing, Packaging or Shipping Problem
3
3
Material Integrity Problem
3
3
No Apparent Adverse Event
3
3
Material Twisted/Bent
3
3
Loss of Osseointegration
3
3
Component Missing
3
3
Human-Device Interface Problem
3
3
Contamination /Decontamination Problem
3
3
Separation Failure
2
2
Difficult to Advance
2
2
Migration or Expulsion of Device
2
2
Protective Measures Problem
2
2
Fitting Problem
2
2
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Unspecified Infection
478
478
Injury
200
200
No Code Available
150
150
No Known Impact Or Consequence To Patient
125
125
Post Operative Wound Infection
121
121
No Clinical Signs, Symptoms or Conditions
119
119
Bacterial Infection
109
109
No Information
65
65
Non-union Bone Fracture
60
60
Device Embedded In Tissue or Plaque
59
59
Inflammation
54
54
Failure of Implant
51
51
Pain
48
48
Foreign Body In Patient
39
39
Insufficient Information
37
37
No Consequences Or Impact To Patient
32
32
Erythema
24
24
Nerve Damage
23
23
Bone Fracture(s)
23
23
Deformity/ Disfigurement
20
20
Impaired Healing
15
15
Loss of Range of Motion
14
14
Malunion of Bone
12
12
Irritation
12
12
Perforation
11
11
Skin Infection
11
11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
11
11
Osteomyelitis
10
10
Swelling
10
10
Thrombosis
9
9
Tissue Breakdown
7
7
Discharge
6
6
Tissue Damage
6
6
Purulent Discharge
6
6
Hematoma
6
6
Arthritis
6
6
Ambulation Difficulties
5
5
Joint Contracture
5
5
Cellulitis
5
5
Ossification
5
5
Necrosis
5
5
Fluid Discharge
5
5
Joint Dislocation
5
5
Hemorrhage/Bleeding
5
5
Abscess
4
4
Sedation
4
4
Fall
4
4
Pulmonary Embolism
4
4
Tingling
3
3
No Patient Involvement
3
3
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet, Inc.
II
Apr-07-2009
2
Musculoskeletal Transplant Foundation, Inc.
II
Jul-24-2015
3
Orthofix Srl
II
Nov-14-2019
4
Orthofix Srl
II
Apr-28-2010
5
Smith & Nephew Inc
II
Jun-06-2012
6
Smith & Nephew Inc
II
Sep-15-2009
7
Zimmer Biomet, Inc.
II
Dec-29-2017
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