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TPLC
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Device
tray, surgical, instrument
Regulation Description
Manual surgical instrument for general use.
Product Code
FSM
Regulation Number
878.4800
Device Class
1
MDR Year
MDR Reports
MDR Events
2020
148
148
2021
153
153
2022
200
200
2023
170
170
2024
288
288
2025
30
30
Device Problems
MDRs with this Device Problem
Events in those MDRs
Peeled/Delaminated
467
467
Break
172
172
Contamination /Decontamination Problem
158
158
Crack
88
88
Naturally Worn
79
79
Flaked
41
41
Material Discolored
40
40
Fracture
39
39
Material Twisted/Bent
29
29
Material Integrity Problem
21
21
No Apparent Adverse Event
18
18
Corroded
18
18
Component Missing
13
13
Unsealed Device Packaging
12
12
Scratched Material
12
12
Material Deformation
12
12
Incorrect Measurement
11
11
Material Fragmentation
11
11
Adverse Event Without Identified Device or Use Problem
9
9
Illegible Information
9
9
Detachment of Device or Device Component
7
7
Appropriate Term/Code Not Available
6
6
Mechanical Problem
5
5
Device-Device Incompatibility
4
4
Degraded
4
4
Use of Device Problem
4
4
Structural Problem
4
4
Product Quality Problem
3
3
Dull, Blunt
2
2
Sparking
2
2
Microbial Contamination of Device
2
2
Device Reprocessing Problem
2
2
Premature Separation
2
2
Defective Device
2
2
Connection Problem
2
2
Overheating of Device
2
2
Residue After Decontamination
2
2
Entrapment of Device
2
2
Device Contaminated During Manufacture or Shipping
1
1
Particulates
1
1
Mechanical Jam
1
1
Delivered as Unsterile Product
1
1
Contamination
1
1
Melted
1
1
Failure to Deliver Energy
1
1
Electrical /Electronic Property Problem
1
1
Defective Component
1
1
Inadequate Instructions for Healthcare Professional
1
1
Inaccurate Information
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
770
770
No Consequences Or Impact To Patient
101
101
Insufficient Information
86
86
No Patient Involvement
14
14
No Known Impact Or Consequence To Patient
11
11
No Code Available
11
11
Not Applicable
5
5
Failure of Implant
3
3
Foreign Body In Patient
3
3
Laceration(s)
3
3
Metal Related Pathology
2
2
Bacterial Infection
1
1
Exposure to Body Fluids
1
1
Bradycardia
1
1
Burn(s)
1
1
Death
1
1
Bone Fracture(s)
1
1
Hematoma
1
1
Hemorrhage/Bleeding
1
1
Unspecified Infection
1
1
Injury
1
1
Joint Dislocation
1
1
Post Operative Wound Infection
1
1
Blood Loss
1
1
Inadequate Osseointegration
1
1
Patient Problem/Medical Problem
1
1
Device Embedded In Tissue or Plaque
1
1
No Information
1
1
Loss of Range of Motion
1
1
Joint Laxity
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Aesculap Implant Systems LLC
II
Apr-25-2023
2
Howmedica Osteonics Corp.
II
Jan-06-2022
3
MEDLINE INDUSTRIES, LP - Northfield
II
Sep-06-2024
4
MEDLINE INDUSTRIES, LP - Northfield
I
Feb-25-2024
5
Medical Action Industries, Inc. 306
II
Sep-12-2024
6
Stradis Healthcare
II
Jan-11-2023
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