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TPLC
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show TPLC since
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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
A&E MEDICAL CORPORATION
SUBSTANTIALLY EQUIVALENT
3
ARTHREX, INC
SUBSTANTIALLY EQUIVALENT
1
ARTHREX, INC.
SUBSTANTIALLY EQUIVALENT
1
BIOMET SPORTS MEDICINE
SUBSTANTIALLY EQUIVALENT
1
BIOMET, INC.
SUBSTANTIALLY EQUIVALENT
1
CABLE FIX MEDICAL LLC
SUBSTANTIALLY EQUIVALENT
1
CIRCUMFIX SOLUTIONS, INC.
SUBSTANTIALLY EQUIVALENT
1
DALLEN MEDICAL
SUBSTANTIALLY EQUIVALENT
1
DALLEN MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
DSM BIOMEDICAL
SUBSTANTIALLY EQUIVALENT
1
FIGURE 8 SURGICAL, INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
FRONTIER MEDICAL DEVICES, INC.
SUBSTANTIALLY EQUIVALENT
3
GLOBUS MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
HOWMEDICA OSTEONICS CORP., DBA STRYKER ORTHOPAEDICS
SUBSTANTIALLY EQUIVALENT
1
IMPLANET S.A.
SUBSTANTIALLY EQUIVALENT
1
K2M, INC.
SUBSTANTIALLY EQUIVALENT
1
KINAMED INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
KINAMED, INCORPORATED
SUBSTANTIALLY EQUIVALENT
1
KLS MARTIN L.P.
SUBSTANTIALLY EQUIVALENT
1
MEDICREA INTERNATIONAL
SUBSTANTIALLY EQUIVALENT
1
NEOS SURGERY SL
SUBSTANTIALLY EQUIVALENT
2
PIONEER SURGICAL TECHNOLOGY, INC
SUBSTANTIALLY EQUIVALENT
1
PIONEER SURGICAL TECHNOLOGY, INC. (DBA RTI SURGICAL, INC.)
SUBSTANTIALLY EQUIVALENT
3
PIONEER SURGICAL TECHNOLOGY, INC. DBA RTI SURGICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
RIVERPOINT MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
SIC BREVETTI S.R.L.
SUBSTANTIALLY EQUIVALENT
1
SMITH & NEPHEW, INC.
SUBSTANTIALLY EQUIVALENT
1
SPINAL ELEMENTS, INC.
SUBSTANTIALLY EQUIVALENT
1
SYNTHES (USA)
SUBSTANTIALLY EQUIVALENT
1
SYNTHES (USA) PRODUCTS LLC/DEPUY ORTHOPAEDICS INC
SUBSTANTIALLY EQUIVALENT
1
ZIMMER SPINE, INC
SUBSTANTIALLY EQUIVALENT
1
ZIMMER, INC.
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2014
223
223
2015
205
205
2016
223
223
2017
138
138
2018
182
182
2019
159
159
2020
124
124
2021
141
141
2022
134
134
2023
98
98
2024
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
368
368
Break
366
366
Device Operates Differently Than Expected
249
249
Mechanical Problem
180
180
Insufficient Information
90
90
Fracture
63
63
Device-Device Incompatibility
35
35
Failure To Adhere Or Bond
34
34
Device Slipped
29
29
Mechanical Jam
29
29
Migration
23
23
Unintended Movement
21
21
Migration or Expulsion of Device
21
21
Loose or Intermittent Connection
20
20
Appropriate Term/Code Not Available
19
19
Sticking
16
16
Component Missing
15
15
Material Deformation
13
13
Material Frayed
12
12
No Apparent Adverse Event
12
12
Device Dislodged or Dislocated
11
11
Bent
9
9
Difficult to Advance
8
8
Material Integrity Problem
7
7
Material Fragmentation
7
7
Material Separation
7
7
Device Difficult to Maintain
7
7
Detachment of Device or Device Component
6
6
Difficult to Open or Close
5
5
Failure to Cut
5
5
Device Handling Problem
5
5
Device Issue
4
4
Dull, Blunt
4
4
Device Operational Issue
4
4
Difficult to Remove
4
4
Detachment Of Device Component
4
4
Corroded
4
4
Crack
3
3
Loss of or Failure to Bond
3
3
Device Reprocessing Problem
3
3
Entrapment of Device
3
3
Difficult to Insert
3
3
Device Disinfection Or Sterilization Issue
3
3
Device Contamination with Chemical or Other Material
3
3
Failure to Advance
3
3
Inadequacy of Device Shape and/or Size
3
3
Fitting Problem
3
3
Defective Component
2
2
Failure to Osseointegrate
2
2
Use of Device Problem
2
2
Separation Failure
2
2
Defective Device
2
2
Loss of Osseointegration
2
2
Incorrect Device Or Component Shipped
2
2
Material Protrusion/Extrusion
2
2
Patient-Device Incompatibility
2
2
Device Packaging Compromised
2
2
Difficult To Position
2
2
Device Difficult to Setup or Prepare
2
2
Product Quality Problem
2
2
Device Appears to Trigger Rejection
2
2
Material Rupture
2
2
Device Inoperable
2
2
Material Disintegration
2
2
Degraded
2
2
Patient Device Interaction Problem
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Naturally Worn
2
2
Packaging Problem
2
2
Positioning Problem
1
1
Temperature Problem
1
1
Therapeutic or Diagnostic Output Failure
1
1
No Fail-Safe Mechanism
1
1
Mechanics Altered
1
1
Material Split, Cut or Torn
1
1
Physical Resistance/Sticking
1
1
Disassembly
1
1
Material Discolored
1
1
Disconnection
1
1
Failure to Charge
1
1
Component Falling
1
1
Contamination
1
1
Device Expiration Issue
1
1
Unraveled Material
1
1
Unstable
1
1
Shelf Life Exceeded
1
1
Off-Label Use
1
1
Delivered as Unsterile Product
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Device Markings/Labelling Problem
1
1
Material Distortion
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Cut In Material
1
1
Tear, Rip or Hole in Device Packaging
1
1
Malposition of Device
1
1
Physical Resistance
1
1
Metal Shedding Debris
1
1
Improper or Incorrect Procedure or Method
1
1
Microbial Contamination of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
333
333
No Clinical Signs, Symptoms or Conditions
206
206
No Code Available
182
182
Unspecified Infection
182
182
Pain
175
175
No Patient Involvement
158
158
No Consequences Or Impact To Patient
149
149
Non-union Bone Fracture
98
98
Failure of Implant
98
98
Injury
48
48
Bone Fracture(s)
46
46
Impaired Healing
43
43
No Information
36
36
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Post Operative Wound Infection
17
17
Wound Dehiscence
17
17
Death
16
16
Reaction
16
16
Inflammation
15
15
Fall
14
14
Insufficient Information
14
14
Device Embedded In Tissue or Plaque
14
14
Hypersensitivity/Allergic reaction
13
13
Hemorrhage/Bleeding
11
11
Joint Dislocation
11
11
Hematoma
9
9
Swelling
8
8
Loss of Range of Motion
7
7
Sepsis
7
7
Discomfort
7
7
Ambulation Difficulties
7
7
Foreign Body In Patient
7
7
Metal Related Pathology
7
7
Unspecified Tissue Injury
6
6
Not Applicable
6
6
Hip Fracture
6
6
Adhesion(s)
6
6
Edema
5
5
Irritation
5
5
Patient Problem/Medical Problem
5
5
Osteolysis
4
4
Tissue Damage
4
4
Necrosis
4
4
Bacterial Infection
4
4
Arthritis
3
3
Joint Disorder
3
3
Malunion of Bone
3
3
Joint Contracture
2
2
Swelling/ Edema
2
2
Disability
2
2
Sedation
2
2
Toxicity
2
2
Nerve Damage
2
2
Neurological Deficit/Dysfunction
2
2
Inadequate Osseointegration
2
2
Osteopenia/ Osteoporosis
2
2
Limited Mobility Of The Implanted Joint
2
2
Fluid Discharge
2
2
Infarction, Cerebral
2
2
Chest Pain
2
2
Abscess
2
2
Burn(s)
2
2
Ossification
2
2
Ischemia
2
2
Laceration(s)
1
1
Damage to Ligament(s)
1
1
Muscular Rigidity
1
1
Nausea
1
1
Foreign Body Reaction
1
1
Granuloma
1
1
Headache
1
1
Pulmonary Embolism
1
1
Abdominal Pain
1
1
Host-Tissue Reaction
1
1
Cardiac Arrest
1
1
Cellulitis
1
1
Purulent Discharge
1
1
Cyst(s)
1
1
Blood Loss
1
1
Organ Dehiscence
1
1
Sudden Cardiac Death
1
1
Obstruction/Occlusion
1
1
Neck Pain
1
1
Synovitis
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Muscle/Tendon Damage
1
1
Blister
1
1
Solid Tumour
1
1
Balance Problems
1
1
Joint Laxity
1
1
Fibrosis
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Alto Development Corp
II
Oct-30-2019
2
EXP Pharmaceutical Services Corp
II
Jul-24-2015
3
PIONEER SURGICAL TECHNOLOGY, INC.
II
Jul-17-2014
4
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
II
Jul-09-2015
5
Smith & Nephew Inc
II
Aug-10-2010
6
Synthes (USA) Products LLC
II
Nov-14-2015
7
Synthes (USA) Products LLC
II
Aug-27-2015
8
Synthes USA HQ, Inc.
II
Oct-30-2013
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