Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
510(k)
|
DeNovo
|
Registration & Listing
|
Adverse Events
|
Recalls
|
PMA
|
HDE
|
Classification
|
Standards
CFR Title 21
|
Radiation-Emitting Products
|
X-Ray Assembler
|
Medsun Reports
|
CLIA
|
TPLC
New Search
show TPLC since
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
cerclage, fixation
Regulation Description
Bone fixation cerclage.
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
MEDACTA INTERNATIONAL S.A.
SUBSTANTIALLY EQUIVALENT
1
NEOS SURGERY SL
SUBSTANTIALLY EQUIVALENT
2
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
2020
124
124
2021
141
141
2022
134
134
2023
98
98
2024
115
115
2025
6
6
Device Problems
MDRs with this Device Problem
Events in those MDRs
Mechanical Problem
166
166
Adverse Event Without Identified Device or Use Problem
156
156
Break
153
153
Device-Device Incompatibility
33
33
Fracture
30
30
Migration
24
24
Device Slipped
19
19
Insufficient Information
16
16
Material Deformation
12
12
Crack
6
6
Migration or Expulsion of Device
5
5
Material Frayed
5
5
Material Fragmentation
5
5
Failure to Cut
5
5
No Apparent Adverse Event
5
5
Appropriate Term/Code Not Available
4
4
Material Separation
3
3
Entrapment of Device
3
3
Product Quality Problem
2
2
Detachment of Device or Device Component
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Material Integrity Problem
2
2
Patient Device Interaction Problem
2
2
Device Appears to Trigger Rejection
2
2
Failure to Osseointegrate
2
2
Defective Component
2
2
Patient-Device Incompatibility
2
2
Malposition of Device
1
1
Physical Resistance/Sticking
1
1
No Fail-Safe Mechanism
1
1
Mechanical Jam
1
1
Connection Problem
1
1
Loss of Osseointegration
1
1
Temperature Problem
1
1
Material Disintegration
1
1
Unraveled Material
1
1
Device Contamination with Chemical or Other Material
1
1
Device Difficult to Setup or Prepare
1
1
Unintended Movement
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Nonstandard Device
1
1
Defective Device
1
1
Therapeutic or Diagnostic Output Failure
1
1
Naturally Worn
1
1
Degraded
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
268
268
Unspecified Infection
66
66
Pain
44
44
Non-union Bone Fracture
43
43
Insufficient Information
40
40
No Code Available
37
37
Failure of Implant
31
31
No Consequences Or Impact To Patient
27
27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
No Known Impact Or Consequence To Patient
13
13
Post Operative Wound Infection
12
12
Bone Fracture(s)
11
11
No Patient Involvement
11
11
Hypersensitivity/Allergic reaction
10
10
Metal Related Pathology
9
9
Fall
9
9
Unspecified Tissue Injury
7
7
Hemorrhage/Bleeding
7
7
Adhesion(s)
6
6
Death
6
6
Hip Fracture
6
6
Inflammation
5
5
Discomfort
5
5
Foreign Body In Patient
5
5
Malunion of Bone
5
5
Injury
4
4
Loss of Range of Motion
4
4
Swelling/ Edema
4
4
Joint Dislocation
3
3
Hematoma
3
3
Inadequate Osseointegration
3
3
Bacterial Infection
3
3
Impaired Healing
3
3
Fluid Discharge
3
3
Wound Dehiscence
2
2
Cellulitis
2
2
Ossification
2
2
Joint Contracture
2
2
Nerve Damage
2
2
Edema
2
2
Scar Tissue
2
2
Osteolysis
1
1
Muscle/Tendon Damage
1
1
Bruise/Contusion
1
1
Pneumonia
1
1
Erosion
1
1
Abscess
1
1
Foreign Body Reaction
1
1
Balance Problems
1
1
Cyst(s)
1
1
-
-