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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 102 102

Device Problems MDRs with this Device Problem Events in those MDRs
Calibration Problem 222 222
Break 186 188
Device-Device Incompatibility 123 124
Fracture 103 103
Material Deformation 64 64
Naturally Worn 57 57
Material Integrity Problem 28 28
Material Twisted/Bent 26 26
Mechanical Problem 25 25
Unintended Movement 20 20
Detachment of Device or Device Component 20 20
Mechanical Jam 16 16
Corroded 14 14
Crack 13 13
Scratched Material 12 12
Failure to Cut 9 9
Compatibility Problem 4 4
No Apparent Adverse Event 4 4
Contamination /Decontamination Problem 4 4
Component Missing 4 4
Use of Device Problem 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
Failure to Calibrate 2 2
Appropriate Term/Code Not Available 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
Shipping Damage or Problem 1 1
Activation Failure 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Difficult to Advance 1 1
Accessory Incompatible 1 1
Connection Problem 1 1
Activation, Positioning or Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 644 646
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
Patient Problem/Medical Problem 1 1
Not Applicable 1 1
Bone Fracture(s) 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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