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TPLC
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Device
retractor
Product Code
GAD
Regulation Number
878.4800
Device Class
1
Premarket Reviews
Manufacturer
Decision
J.R. PARKER, LLC
SUBSTANTIALLY EQUIVALENT
1
SPINEART
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2016
78
78
2017
90
90
2018
77
77
2019
62
62
2020
86
86
2021
81
81
2022
80
80
2023
80
80
2024
33
33
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
233
233
Device-Device Incompatibility
47
47
Detachment of Device or Device Component
46
46
Crack
45
45
Adverse Event Without Identified Device or Use Problem
33
33
Fracture
29
29
Material Integrity Problem
27
27
Material Deformation
26
26
Compatibility Problem
25
25
Material Twisted/Bent
17
17
Detachment Of Device Component
16
16
Difficult to Remove
15
15
Mechanical Jam
14
14
Component Missing
13
13
Material Fragmentation
13
13
Mechanical Problem
11
11
Device Operates Differently Than Expected
11
11
Appropriate Term/Code Not Available
9
9
Disassembly
7
7
Device Slipped
6
6
Use of Device Problem
6
6
Fitting Problem
6
6
Contamination /Decontamination Problem
5
5
Insufficient Information
5
5
Positioning Problem
5
5
Mechanics Altered
5
5
Material Separation
5
5
Scratched Material
4
4
Difficult to Open or Close
4
4
Patient Device Interaction Problem
4
4
Physical Resistance/Sticking
3
3
Device Dislodged or Dislocated
3
3
Overheating of Device
3
3
Difficult or Delayed Positioning
3
3
Failure To Adhere Or Bond
3
3
Bent
3
3
Device Reprocessing Problem
2
2
Component Falling
2
2
Positioning Failure
2
2
Difficult to Insert
2
2
Entrapment of Device
2
2
Improper or Incorrect Procedure or Method
2
2
Sticking
2
2
Product Quality Problem
2
2
Temperature Problem
2
2
Unintended Movement
2
2
Device Difficult to Maintain
2
2
Naturally Worn
2
2
Excessive Heating
2
2
Material Split, Cut or Torn
2
2
Device Handling Problem
2
2
Separation Problem
1
1
Sharp Edges
1
1
Device Fell
1
1
Material Distortion
1
1
Packaging Problem
1
1
No Apparent Adverse Event
1
1
Therapeutic or Diagnostic Output Failure
1
1
Torn Material
1
1
Connection Problem
1
1
Activation, Positioning or Separation Problem
1
1
Tear, Rip or Hole in Device Packaging
1
1
Dull, Blunt
1
1
Failure to Align
1
1
Failure to Advance
1
1
Defective Device
1
1
Fail-Safe Problem
1
1
Device Contamination with Chemical or Other Material
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Difficult to Open or Remove Packaging Material
1
1
Device Markings/Labelling Problem
1
1
Device Inoperable
1
1
Shipping Damage or Problem
1
1
Smoking
1
1
Material Erosion
1
1
No Device Output
1
1
Failure to Power Up
1
1
Device Difficult to Setup or Prepare
1
1
Incorrect, Inadequate or Imprecise Result or Readings
1
1
Retraction Problem
1
1
Inadequate Instructions for Healthcare Professional
1
1
Leak/Splash
1
1
Material Discolored
1
1
Degraded
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
107
107
No Consequences Or Impact To Patient
104
104
No Patient Involvement
62
62
No Information
26
26
Foreign Body In Patient
18
18
Device Embedded In Tissue or Plaque
17
17
Insufficient Information
17
17
No Code Available
16
16
Injury
9
9
Hemorrhage/Bleeding
6
6
Bone Fracture(s)
5
5
Pain
5
5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
5
5
Cancer
4
4
Burn, Thermal
4
4
Blood Loss
4
4
Hematoma
4
4
Tissue Damage
4
4
Burn(s)
4
4
Liver Damage/Dysfunction
3
3
Not Applicable
3
3
Skin Tears
3
3
Bowel Perforation
2
2
Superficial (First Degree) Burn
2
2
Numbness
2
2
Post Operative Wound Infection
2
2
Necrosis
2
2
Swelling
2
2
Sedation
2
2
Perforation of Vessels
2
2
Vomiting
1
1
Ulcer
1
1
Discomfort
1
1
Joint Dislocation
1
1
Osteolysis
1
1
Vertigo
1
1
Perforation
1
1
Pneumonia
1
1
Rash
1
1
Respiratory Distress
1
1
Seroma
1
1
Neuropathy
1
1
Muscle Weakness
1
1
Nausea
1
1
Failure of Implant
1
1
Unspecified Infection
1
1
Laceration(s)
1
1
Death
1
1
Exsanguination
1
1
Granuloma
1
1
Wound Dehiscence
1
1
Pulmonary Embolism
1
1
Abdominal Pain
1
1
Atrial Fibrillation
1
1
Shaking/Tremors
1
1
Spinal Cord Injury
1
1
Weight Changes
1
1
Cognitive Changes
1
1
Patient Problem/Medical Problem
1
1
Partial thickness (Second Degree) Burn
1
1
Unspecified Heart Problem
1
1
Blister
1
1
Unspecified Tissue Injury
1
1
Unintended Radiation Exposure
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
AAP Implantate Ag
II
Apr-06-2020
2
Applied Medical Technology Inc
II
May-05-2016
3
Biomet, Inc.
II
Mar-10-2016
4
CooperSurgical, Inc.
II
Sep-27-2018
5
MEDLINE INDUSTRIES, LP - Northfield
II
Mar-29-2024
6
Medagent Inc
II
Feb-23-2024
7
Medtronic Navigation, Inc.
II
Jan-12-2023
8
Smith & Nephew, Inc.
II
Aug-17-2020
9
Synthes (USA) Products LLC
II
May-09-2018
10
TELEFLEX LLC
II
Jul-05-2023
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