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TPLC
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show TPLC since
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2024
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Device
cerclage, fixation
Product Code
JDQ
Regulation Number
888.3010
Device Class
2
Premarket Reviews
Manufacturer
Decision
A&E MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
1
ARTHREX, INC
SUBSTANTIALLY EQUIVALENT
1
CIRCUMFIX SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
GLOBUS MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
NEOS SURGERY SL
SUBSTANTIALLY EQUIVALENT
2
1. K211613
Stern Fix Sternal Stabilization System
2. K221795
STERN FIX Sternal Stabilization System
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
SUBSTANTIALLY EQUIVALENT
2
RIVERPOINT MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2019
159
159
2020
124
124
2021
141
141
2022
134
134
2023
98
98
2024
17
17
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
187
187
Adverse Event Without Identified Device or Use Problem
165
165
Mechanical Problem
154
154
Device-Device Incompatibility
30
30
Fracture
27
27
Migration
23
23
Device Slipped
21
21
Insufficient Information
17
17
No Apparent Adverse Event
12
12
Material Frayed
8
8
Material Deformation
6
6
Device Difficult to Maintain
6
6
Failure to Cut
5
5
Migration or Expulsion of Device
5
5
Material Separation
4
4
Appropriate Term/Code Not Available
4
4
Material Fragmentation
3
3
Entrapment of Device
3
3
Material Integrity Problem
3
3
Patient-Device Incompatibility
2
2
Defective Component
2
2
Use of Device Problem
2
2
Failure to Osseointegrate
2
2
Degraded
2
2
Product Quality Problem
2
2
Device Appears to Trigger Rejection
2
2
Patient Device Interaction Problem
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Material Split, Cut or Torn
1
1
Physical Resistance/Sticking
1
1
Device Handling Problem
1
1
Packaging Problem
1
1
Temperature Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
Unintended Movement
1
1
Delivered as Unsterile Product
1
1
Device Difficult to Setup or Prepare
1
1
Material Disintegration
1
1
Corroded
1
1
Crack
1
1
Loss of or Failure to Bond
1
1
Improper or Incorrect Procedure or Method
1
1
Component Missing
1
1
Loss of Osseointegration
1
1
Defective Device
1
1
Malposition of Device
1
1
Connection Problem
1
1
Detachment of Device or Device Component
1
1
Device Contamination with Chemical or Other Material
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Mechanical Jam
1
1
Naturally Worn
1
1
No Fail-Safe Mechanism
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
211
211
No Consequences Or Impact To Patient
100
100
No Code Available
85
85
Unspecified Infection
70
70
Pain
55
55
Non-union Bone Fracture
44
44
Failure of Implant
38
38
No Patient Involvement
23
23
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Bone Fracture(s)
20
20
Insufficient Information
18
18
No Known Impact Or Consequence To Patient
17
17
Injury
15
15
Hypersensitivity/Allergic reaction
12
12
Post Operative Wound Infection
12
12
Inflammation
10
10
Fall
9
9
Metal Related Pathology
7
7
Reaction
6
6
Unspecified Tissue Injury
6
6
Hematoma
6
6
Adhesion(s)
6
6
Wound Dehiscence
6
6
Death
6
6
Edema
5
5
Hip Fracture
5
5
Foreign Body In Patient
5
5
Loss of Range of Motion
4
4
Impaired Healing
4
4
Joint Dislocation
3
3
Bacterial Infection
3
3
Hemorrhage/Bleeding
3
3
Not Applicable
3
3
Malunion of Bone
3
3
Swelling/ Edema
2
2
No Information
2
2
Patient Problem/Medical Problem
2
2
Fluid Discharge
2
2
Joint Contracture
2
2
Ossification
2
2
Nerve Damage
2
2
Osteolysis
1
1
Inadequate Osseointegration
1
1
Osteopenia/ Osteoporosis
1
1
Limited Mobility Of The Implanted Joint
1
1
Sepsis
1
1
Tissue Damage
1
1
Abscess
1
1
Burn(s)
1
1
Cellulitis
1
1
Cyst(s)
1
1
Foreign Body Reaction
1
1
Muscular Rigidity
1
1
Necrosis
1
1
Balance Problems
1
1
Joint Laxity
1
1
Muscle/Tendon Damage
1
1
Blister
1
1
Solid Tumour
1
1
Device Embedded In Tissue or Plaque
1
1
Fibrosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Alto Development Corp
II
Oct-30-2019
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