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TPLC
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show TPLC since
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Device
screw, fixation, intraosseous
Product Code
DZL
Regulation Number
872.4880
Device Class
2
Premarket Reviews
Manufacturer
Decision
BIOMET SPORTS MEDICINE
SUBSTANTIALLY EQUIVALENT
1
DENTIS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
ELI-KA TECHNOLOGIES
SUBSTANTIALLY EQUIVALENT
1
HAGER & MEISINGER GMBH
SUBSTANTIALLY EQUIVALENT
4
INTRA-LOCK INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
1
JEIL MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S
SUBSTANTIALLY EQUIVALENT
1
KLS MARTIN L.P.
SUBSTANTIALLY EQUIVALENT
1
KLS-MARTIN L.P.
SUBSTANTIALLY EQUIVALENT
1
MILTEX, INC.
SUBSTANTIALLY EQUIVALENT
1
NEOBIOTECH CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
NEOSS LIMITED
SUBSTANTIALLY EQUIVALENT
1
OSSTEM IMPLANT CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
OSSTEM IMPLANT CO., LTD..
SUBSTANTIALLY EQUIVALENT
1
OSTEOGENICS BIOMEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
OSTEOMED
SUBSTANTIALLY EQUIVALENT
1
SALVIN DENTAL SPECIALTIES
SUBSTANTIALLY EQUIVALENT
1
SALVIN DENTAL SPECIALTIES, INC.
SUBSTANTIALLY EQUIVALENT
1
STRYKER LEIBINGER GMBH & CO. KG
SUBSTANTIALLY EQUIVALENT
1
SYNTHES (USA)
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
106
106
2015
103
103
2016
34
34
2017
74
74
2018
57
57
2019
50
50
2020
85
85
2021
55
55
2022
162
162
2023
100
100
2024
89
89
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
396
396
Adverse Event Without Identified Device or Use Problem
168
168
Fracture
98
98
Physical Resistance/Sticking
47
47
Patient Device Interaction Problem
41
41
Material Fragmentation
31
31
Mechanical Jam
23
23
Entrapment of Device
21
21
Unintended Movement
16
16
Material Twisted/Bent
12
12
Loose or Intermittent Connection
10
10
Nonstandard Device
10
10
Manufacturing, Packaging or Shipping Problem
10
10
Difficult to Remove
9
9
Detachment Of Device Component
8
8
Difficult to Advance
8
8
Migration or Expulsion of Device
7
7
Failure to Advance
7
7
Device Dislodged or Dislocated
6
6
Migration
5
5
Detachment of Device or Device Component
5
5
Use of Device Problem
5
5
Signal Artifact/Noise
5
5
Patient-Device Incompatibility
5
5
Difficult to Insert
4
4
Improper or Incorrect Procedure or Method
4
4
Naturally Worn
4
4
Device Operates Differently Than Expected
4
4
Insufficient Information
3
3
Material Deformation
3
3
Crack
3
3
Off-Label Use
3
3
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Difficult or Delayed Activation
2
2
Device-Device Incompatibility
2
2
Bent
2
2
Material Rupture
2
2
Firing Problem
2
2
Retraction Problem
2
2
Failure to Fire
2
2
Activation Failure
2
2
Noise, Audible
1
1
Hole In Material
1
1
Component Falling
1
1
Device Slipped
1
1
Premature Separation
1
1
Device Or Device Fragments Location Unknown
1
1
Device Contaminated During Manufacture or Shipping
1
1
Malposition of Device
1
1
Failure to Eject
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
249
249
No Known Impact Or Consequence To Patient
137
137
No Consequences Or Impact To Patient
83
83
Foreign Body In Patient
81
81
Unspecified Infection
80
80
No Code Available
67
67
Device Embedded In Tissue or Plaque
55
55
No Information
46
46
Insufficient Information
39
39
Impaired Healing
25
25
Sedation
23
23
Pain
21
21
Failure of Implant
19
19
Non-union Bone Fracture
16
16
Discomfort
15
15
Hypersensitivity/Allergic reaction
8
8
Unspecified Musculoskeletal problem
8
8
Nerve Damage
8
8
Airway Obstruction
7
7
No Patient Involvement
6
6
Staphylococcus Aureus
5
5
Fatigue
5
5
Injury
4
4
Loss of consciousness
4
4
Bone Fracture(s)
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Post Operative Wound Infection
2
2
Ossification
2
2
Loss of Range of Motion
2
2
Inflammation
2
2
Swelling/ Edema
2
2
Physical Asymmetry
2
2
Pressure Sores
2
2
Difficulty Chewing
2
2
Sleep Dysfunction
2
2
Irritation
1
1
Tooth Fracture
1
1
Limited Mobility Of The Implanted Joint
1
1
Eye Injury
1
1
Reaction
1
1
Fluid Discharge
1
1
Decreased Sensitivity
1
1
Host-Tissue Reaction
1
1
Tissue Damage
1
1
Complaint, Ill-Defined
1
1
Increased Sensitivity
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Biomet 3i, LLC
II
Jul-06-2010
2
Biomet Microfixation, Inc.
III
Aug-11-2010
3
Synthes (USA) Products LLC
II
Apr-05-2016
4
Synthes USA HQ, Inc.
II
Jul-17-2013
5
Synthes USA HQ, Inc.
II
Mar-01-2013
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