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TPLC
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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
734
734
2021
794
794
2022
581
581
2023
675
675
Device Problems
MDRs with this Device Problem
Events in those MDRs
Device-Device Incompatibility
1412
1412
Break
897
897
Material Deformation
293
293
Adverse Event Without Identified Device or Use Problem
229
229
Material Twisted/Bent
196
196
Fracture
186
186
Device Contaminated During Manufacture or Shipping
97
97
Mechanical Jam
96
96
Entrapment of Device
59
59
Failure to Align
56
56
Material Integrity Problem
47
47
Use of Device Problem
44
44
Packaging Problem
40
40
Unstable
38
38
Device Operates Differently Than Expected
34
34
Detachment of Device or Device Component
30
30
Component Missing
21
21
Material Separation
20
20
Mechanical Problem
19
19
Appropriate Term/Code Not Available
18
18
Connection Problem
17
17
Contamination /Decontamination Problem
15
15
Device Difficult to Maintain
15
15
Tear, Rip or Hole in Device Packaging
14
14
Corroded
14
14
Degraded
14
14
Device Markings/Labelling Problem
13
13
Physical Resistance/Sticking
13
13
Fitting Problem
12
12
Defective Device
11
11
Crack
11
11
Difficult to Remove
10
10
Bent
9
9
Device Slipped
9
9
Manufacturing, Packaging or Shipping Problem
9
9
Incomplete or Inadequate Connection
9
9
Compatibility Problem
8
8
Separation Failure
8
8
Loose or Intermittent Connection
8
8
Improper or Incorrect Procedure or Method
7
7
Device Handling Problem
7
7
Naturally Worn
7
7
No Apparent Adverse Event
6
6
Dull, Blunt
6
6
Incorrect Measurement
6
6
Unsealed Device Packaging
5
5
Peeled/Delaminated
5
5
Material Fragmentation
5
5
Device Operational Issue
5
5
Insufficient Information
5
5
Scratched Material
5
5
Unintended Movement
4
4
Device Packaging Compromised
4
4
Failure to Cut
4
4
Positioning Failure
4
4
Disassembly
4
4
Failure To Adhere Or Bond
3
3
Difficult to Insert
3
3
Delivered as Unsterile Product
3
3
Difficult to Advance
3
3
Difficult or Delayed Separation
3
3
Patient Device Interaction Problem
3
3
Therapeutic or Diagnostic Output Failure
2
2
Misassembled During Installation
2
2
Device Dislodged or Dislocated
2
2
Device Contamination with Chemical or Other Material
2
2
Device Damaged by Another Device
2
2
Device Misassembled During Manufacturing /Shipping
2
2
Component or Accessory Incompatibility
2
2
Malposition of Device
2
2
Device Damaged Prior to Use
2
2
Device Difficult to Setup or Prepare
2
2
Off-Label Use
2
2
Misassembled
2
2
Labelling, Instructions for Use or Training Problem
2
2
Detachment Of Device Component
2
2
Accessory Incompatible
1
1
Material Discolored
1
1
Flaked
1
1
Product Quality Problem
1
1
No Device Output
1
1
Overheating of Device
1
1
Sticking
1
1
Unexpected Therapeutic Results
1
1
Residue After Decontamination
1
1
Metal Shedding Debris
1
1
Patient-Device Incompatibility
1
1
Calibration Problem
1
1
Installation-Related Problem
1
1
Inaccurate Information
1
1
Unintended Compatibility
1
1
Noise, Audible
1
1
Sharp Edges
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
Physical Property Issue
1
1
Positioning Problem
1
1
Osseointegration Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
1844
1844
No Consequences Or Impact To Patient
784
784
No Patient Involvement
390
390
No Known Impact Or Consequence To Patient
197
197
No Code Available
148
148
Foreign Body In Patient
104
104
Unspecified Infection
87
87
Joint Laxity
78
78
Insufficient Information
74
74
Injury
37
37
No Information
34
34
Not Applicable
24
24
Implant Pain
22
22
Failure of Implant
14
14
Device Embedded In Tissue or Plaque
12
12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
12
12
Unspecified Tissue Injury
10
10
Tissue Damage
7
7
Bone Fracture(s)
6
6
Pain
5
5
Loss of Range of Motion
4
4
Scar Tissue
2
2
Swelling
2
2
Numbness
2
2
Hypersensitivity/Allergic reaction
2
2
Inflammation
2
2
Fall
2
2
Foreign Body Reaction
1
1
Hemorrhage, Subarachnoid
1
1
Abrasion
1
1
Awareness during Anaesthesia
1
1
Burn(s)
1
1
Death
1
1
Damage to Ligament(s)
1
1
Muscular Rigidity
1
1
Perforation
1
1
Blood Loss
1
1
Pseudoaneurysm
1
1
Arthralgia
1
1
Joint Dislocation
1
1
Rupture
1
1
Brain Injury
1
1
Inadequate Osseointegration
1
1
Swelling/ Edema
1
1
Muscle/Tendon Damage
1
1
Osteomyelitis
1
1
Cramp(s) /Muscle Spasm(s)
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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