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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
MEDACTA INTERNATIONAL S.A.
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
37
37
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
377
377
Break
375
375
Device Operates Differently Than Expected
249
249
Mechanical Problem
189
189
Insufficient Information
90
90
Fracture
64
64
Device-Device Incompatibility
40
40
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
Material Deformation
19
19
Appropriate Term/Code Not Available
19
19
Sticking
16
16
Component Missing
15
15
Material Frayed
12
12
No Apparent Adverse Event
12
12
Device Dislodged or Dislocated
11
11
Bent
9
9
Crack
9
9
Difficult to Advance
8
8
Material Integrity Problem
7
7
Material Separation
7
7
Material Fragmentation
7
7
Device Difficult to Maintain
7
7
Failure to Cut
6
6
Detachment of Device or Device Component
6
6
Difficult to Open or Close
5
5
Device Handling Problem
5
5
Device Operational Issue
4
4
Device Issue
4
4
Dull, Blunt
4
4
Detachment Of Device Component
4
4
Corroded
4
4
Difficult to Remove
4
4
Difficult to Insert
3
3
Device Reprocessing Problem
3
3
Loss of or Failure to Bond
3
3
Entrapment of Device
3
3
Failure to Advance
3
3
Fitting Problem
3
3
Device Disinfection Or Sterilization Issue
3
3
Device Contamination with Chemical or Other Material
3
3
Inadequacy of Device Shape and/or Size
3
3
Patient Device Interaction Problem
2
2
Loosening of Implant Not Related to Bone-Ingrowth
2
2
Naturally Worn
2
2
Packaging Problem
2
2
Incorrect Device Or Component Shipped
2
2
Manufacturing, Packaging or Shipping Problem
2
2
Material Protrusion/Extrusion
2
2
Patient-Device Incompatibility
2
2
Device Packaging Compromised
2
2
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
Degraded
2
2
Material Disintegration
2
2
Difficult To Position
2
2
Device Difficult to Setup or Prepare
2
2
Material Rupture
2
2
Product Quality Problem
2
2
Device Appears to Trigger Rejection
2
2
Device Inoperable
2
2
Unraveled Material
1
1
Unstable
1
1
Off-Label Use
1
1
Delivered as Unsterile Product
1
1
Disassembly
1
1
Material Discolored
1
1
Disconnection
1
1
Device Expiration Issue
1
1
Failure to Charge
1
1
Component Falling
1
1
Contamination
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
Shelf Life Exceeded
1
1
Improper or Incorrect Procedure or Method
1
1
Microbial Contamination of Device
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Device Markings/Labelling Problem
1
1
Material Distortion
1
1
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
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
215
215
Unspecified Infection
187
187
No Code Available
182
182
Pain
175
175
No Patient Involvement
158
158
No Consequences Or Impact To Patient
149
149
Non-union Bone Fracture
100
100
Failure of Implant
99
99
Injury
48
48
Bone Fracture(s)
46
46
Impaired Healing
44
44
No Information
36
36
Insufficient Information
25
25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
22
22
Wound Dehiscence
18
18
Post Operative Wound Infection
17
17
Reaction
16
16
Death
16
16
Inflammation
15
15
Fall
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
7
7
Not Applicable
6
6
Hip Fracture
6
6
Adhesion(s)
6
6
Edema
5
5
Irritation
5
5
Patient Problem/Medical Problem
5
5
Malunion of Bone
5
5
Bacterial Infection
4
4
Necrosis
4
4
Osteolysis
4
4
Tissue Damage
4
4
Joint Disorder
3
3
Arthritis
3
3
Burn(s)
2
2
Ossification
2
2
Abscess
2
2
Cellulitis
2
2
Infarction, Cerebral
2
2
Chest Pain
2
2
Ischemia
2
2
Inadequate Osseointegration
2
2
Osteopenia/ Osteoporosis
2
2
Limited Mobility Of The Implanted Joint
2
2
Fluid Discharge
2
2
Nerve Damage
2
2
Neurological Deficit/Dysfunction
2
2
Sedation
2
2
Disability
2
2
Toxicity
2
2
Joint Contracture
2
2
Swelling/ Edema
2
2
Muscle/Tendon Damage
1
1
Blister
1
1
Solid Tumour
1
1
Fibrosis
1
1
Balance Problems
1
1
Joint Laxity
1
1
Chronic Obstructive Pulmonary Disease (COPD)
1
1
Pleural Effusion
1
1
Pneumonia
1
1
Synovitis
1
1
Blood Loss
1
1
Organ Dehiscence
1
1
Sudden Cardiac Death
1
1
Obstruction/Occlusion
1
1
Neck Pain
1
1
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
Cyst(s)
1
1
Purulent Discharge
1
1
Pulmonary Embolism
1
1
Abdominal Pain
1
1
Host-Tissue Reaction
1
1
Cardiac Arrest
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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