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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device wrench
Regulation Description Orthopedic manual surgical instrument.
Product CodeHXC
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 142 142
2021 160 160
2022 143 144
2023 145 146
2024 125 126
2025 117 117
2026 27 27

Device Problems MDRs with this Device Problem Events in those MDRs
Calibration Problem 234 234
Break 194 196
Device-Device Incompatibility 129 130
Fracture 105 105
Material Deformation 81 81
Naturally Worn 57 57
Material Integrity Problem 28 28
Material Twisted/Bent 26 26
Mechanical Problem 25 25
Crack 23 23
Unintended Movement 20 20
Detachment of Device or Device Component 20 20
Mechanical Jam 16 16
Corroded 14 14
Scratched Material 12 12
Failure to Cut 9 9
Contamination /Decontamination Problem 5 5
Compatibility Problem 4 4
No Apparent Adverse Event 4 4
Use of Device Problem 4 4
Component Missing 4 4
Structural Problem 4 4
Illegible Information 3 3
Degraded 3 3
Adverse Event Without Identified Device or Use Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Appropriate Term/Code Not Available 2 2
Failure to Calibrate 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Separation Failure 2 2
Physical Resistance/Sticking 2 2
Unstable 2 2
Packaging Problem 1 1
Device Handling Problem 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Inadequacy of Device Shape and/or Size 1 1
Shipping Damage or Problem 1 1
Activation Failure 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Advance 1 1
Connection Problem 1 1
Accessory Incompatible 1 1
Activation, Positioning or Separation Problem 1 1
Loss of or Failure to Bond 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 685 687
No Consequences Or Impact To Patient 66 66
Insufficient Information 59 60
No Patient Involvement 31 31
No Known Impact Or Consequence To Patient 13 13
No Code Available 10 10
Foreign Body In Patient 5 5
No Information 4 4
Failure of Implant 2 2
Bone Fracture(s) 2 2
Patient Problem/Medical Problem 1 1
Not Applicable 1 1
Vertebral Fracture 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 New Standard Device Inc II Jun-21-2022
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