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TPLC
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show TPLC since
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Device
guide, surgical, instrument
Product Code
FZX
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2018
447
447
2019
535
535
2020
735
735
2021
795
795
2022
591
591
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device-Device Incompatibility
1198
1198
Break
763
763
Material Deformation
231
231
Fracture
175
175
Material Twisted/Bent
167
167
Device Contaminated During Manufacture or Shipping
97
97
Mechanical Jam
88
88
Entrapment of Device
53
53
Failure to Align
49
49
Packaging Problem
39
39
Use of Device Problem
38
38
Device Operates Differently Than Expected
34
34
Material Integrity Problem
31
31
Adverse Event Without Identified Device or Use Problem
27
27
Detachment of Device or Device Component
26
26
Component Missing
21
21
Mechanical Problem
19
19
Appropriate Term/Code Not Available
18
18
Connection Problem
17
17
Material Separation
16
16
Device Difficult to Maintain
15
15
Physical Resistance/Sticking
14
14
Corroded
14
14
Tear, Rip or Hole in Device Packaging
14
14
Device Markings/Labelling Problem
13
13
Degraded
13
13
Fitting Problem
12
12
Defective Device
11
11
Crack
10
10
Bent
9
9
Difficult to Remove
9
9
Incomplete or Inadequate Connection
9
9
Loose or Intermittent Connection
8
8
Compatibility Problem
8
8
Separation Failure
7
7
Device Handling Problem
7
7
Naturally Worn
6
6
Dull, Blunt
6
6
Manufacturing, Packaging or Shipping Problem
6
6
Improper or Incorrect Procedure or Method
6
6
Device Slipped
6
6
Incorrect Measurement
5
5
Unsealed Device Packaging
5
5
Peeled/Delaminated
5
5
Material Fragmentation
5
5
Device Operational Issue
5
5
Insufficient Information
5
5
Scratched Material
4
4
No Apparent Adverse Event
4
4
Device Packaging Compromised
4
4
Unintended Movement
4
4
Failure to Cut
4
4
Contamination /Decontamination Problem
4
4
Positioning Failure
4
4
Disassembly
4
4
Failure To Adhere Or Bond
3
3
Delivered as Unsterile Product
3
3
Difficult to Advance
3
3
Patient Device Interaction Problem
3
3
Difficult or Delayed Separation
3
3
Misassembled During Installation
2
2
Therapeutic or Diagnostic Output Failure
2
2
Device Dislodged or Dislocated
2
2
Device Contamination with Chemical or Other Material
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Device Damaged by Another Device
2
2
Malposition of Device
2
2
Device Damaged Prior to Use
2
2
Device Difficult to Setup or Prepare
2
2
Detachment Of Device Component
2
2
Difficult to Insert
2
2
Labelling, Instructions for Use or Training Problem
2
2
Flaked
1
1
Accessory Incompatible
1
1
Material Discolored
1
1
Off-Label Use
1
1
Product Quality Problem
1
1
Misassembled
1
1
No Device Output
1
1
Overheating of Device
1
1
Sticking
1
1
Unexpected Therapeutic Results
1
1
Metal Shedding Debris
1
1
Residue After Decontamination
1
1
Patient-Device Incompatibility
1
1
Calibration Problem
1
1
Component or Accessory Incompatibility
1
1
Installation-Related Problem
1
1
Physical Property Issue
1
1
Positioning Problem
1
1
Osseointegration Problem
1
1
Loosening of Implant Not Related to Bone-Ingrowth
1
1
Component Misassembled
1
1
Material Split, Cut or Torn
1
1
Ejection Problem
1
1
Inaccurate Information
1
1
Unintended Compatibility
1
1
Noise, Audible
1
1
Sharp Edges
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1428
1428
No Consequences Or Impact To Patient
784
784
No Patient Involvement
390
390
No Known Impact Or Consequence To Patient
198
198
No Code Available
148
148
Foreign Body In Patient
92
92
Injury
37
37
No Information
34
34
Insufficient Information
26
26
Not Applicable
24
24
Device Embedded In Tissue or Plaque
12
12
Failure of Implant
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Unspecified Tissue Injury
8
8
Tissue Damage
7
7
Unspecified Infection
5
5
Pain
5
5
Bone Fracture(s)
4
4
Loss of Range of Motion
2
2
Scar Tissue
2
2
Swelling
2
2
Inflammation
2
2
Numbness
2
2
Blood Loss
1
1
Pseudoaneurysm
1
1
Inadequate Osseointegration
1
1
Swelling/ Edema
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Joint Laxity
1
1
Muscular Rigidity
1
1
Abrasion
1
1
Awareness during Anaesthesia
1
1
Burn(s)
1
1
Death
1
1
Foreign Body Reaction
1
1
Rupture
1
1
Brain Injury
1
1
Hemorrhage, Subarachnoid
1
1
Perforation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Synthes, Inc.
II
Feb-21-2018
2
Zimmer Biomet, Inc.
II
Nov-22-2019
3
Zimmer Biomet, Inc.
II
Apr-20-2018
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