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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
2019 154 154
2020 142 142
2021 160 160
2022 143 143
2023 145 145
2024 126 126
2025 54 54

Device Problems MDRs with this Device Problem Events in those MDRs
Calibration Problem 258 258
Break 207 207
Device-Device Incompatibility 123 123
Fracture 105 105
Naturally Worn 63 63
Material Deformation 56 56
Mechanical Problem 55 55
Material Twisted/Bent 33 33
Material Integrity Problem 28 28
Mechanical Jam 22 22
Detachment of Device or Device Component 19 19
Crack 16 16
Corroded 14 14
Scratched Material 13 13
Physical Resistance/Sticking 11 11
Unintended Movement 11 11
Component Missing 11 11
Failure to Cut 9 9
Failure to Calibrate 7 7
Use of Device Problem 6 6
Contamination /Decontamination Problem 5 5
Compatibility Problem 4 4
Loose or Intermittent Connection 4 4
Appropriate Term/Code Not Available 4 4
No Apparent Adverse Event 4 4
Illegible Information 3 3
Degraded 3 3
Structural Problem 3 3
Improper or Incorrect Procedure or Method 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Separation Failure 2 2
Unstable 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Difficult to Remove 1 1
Packaging Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Tear, Rip or Hole in Device Packaging 1 1
Defective Component 1 1
Activation Failure 1 1
Difficult to Advance 1 1
Material Disintegration 1 1
Device Damaged Prior to Use 1 1
Connection Problem 1 1
Accessory Incompatible 1 1
Device Contaminated During Manufacture or Shipping 1 1
Activation, Positioning or Separation Problem 1 1
Component or Accessory Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 600 600
No Consequences Or Impact To Patient 149 149
No Patient Involvement 70 70
Insufficient Information 57 57
No Known Impact Or Consequence To Patient 33 33
No Code Available 15 15
No Information 7 7
Foreign Body In Patient 6 6
Not Applicable 5 5
Failure of Implant 2 2
Patient Problem/Medical Problem 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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