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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device reamer
Regulation Description Orthopedic manual surgical instrument.
Product CodeHTO
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 1531 1531
2021 4802 4802
2022 3909 3909
2023 4403 4403
2024 4748 4748
2025 278 278

Device Problems MDRs with this Device Problem Events in those MDRs
Failure to Cut 14556 14556
Naturally Worn 1904 1904
Break 1574 1574
Corroded 1040 1040
Device-Device Incompatibility 713 713
No Apparent Adverse Event 703 703
Material Twisted/Bent 503 503
Adverse Event Without Identified Device or Use Problem 444 444
Dull, Blunt 390 390
Entrapment of Device 359 359
Illegible Information 306 306
Contamination /Decontamination Problem 170 170
Material Deformation 166 166
Fracture 87 87
Crack 84 84
Detachment of Device or Device Component 53 53
Degraded 51 51
Mechanical Jam 50 50
Scratched Material 50 50
Material Integrity Problem 34 34
Device Contaminated During Manufacture or Shipping 33 33
Loose or Intermittent Connection 24 24
Unintended Movement 21 21
Improper or Incorrect Procedure or Method 20 20
Component Missing 15 15
Material Discolored 14 14
Appropriate Term/Code Not Available 12 12
Inaccurate Information 10 10
Structural Problem 9 9
Use of Device Problem 9 9
Physical Resistance/Sticking 7 7
Difficult to Insert 5 5
Material Fragmentation 4 4
Device Slipped 4 4
Defective Device 3 3
Material Disintegration 3 3
Peeled/Delaminated 3 3
Off-Label Use 3 3
Mechanical Problem 3 3
Difficult to Remove 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Product Quality Problem 2 2
Material Separation 2 2
Inadequacy of Device Shape and/or Size 2 2
Insufficient Information 2 2
Device Damaged Prior to Use 2 2
Difficult to Open or Remove Packaging Material 2 2
Difficult to Open or Close 2 2
Noise, Audible 2 2
Battery Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 16953 16953
Insufficient Information 1384 1384
No Consequences Or Impact To Patient 959 959
Foreign Body In Patient 372 372
No Code Available 362 362
Not Applicable 42 42
Unspecified Tissue Injury 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 22 22
Injury 22 22
Limb Fracture 20 20
Bone Fracture(s) 18 18
No Patient Involvement 17 17
No Known Impact Or Consequence To Patient 8 8
Failure of Implant 6 6
Pain 6 6
Unspecified Infection 5 5
Septic Shock 5 5
Loss of Range of Motion 4 4
Shock 4 4
Hemorrhage/Bleeding 4 4
Post Operative Wound Infection 3 3
Device Embedded In Tissue or Plaque 3 3
Discomfort 2 2
Fall 2 2
Non-union Bone Fracture 2 2
Swelling/ Edema 2 2
Hip Fracture 1 1
Hematoma 1 1
Unspecified Nervous System Problem 1 1
Burn(s) 1 1
Nerve Damage 1 1
Laceration(s) 1 1
Hyperextension 1 1
Physical Entrapment 1 1
Perforation of Vessels 1 1
Tissue Damage 1 1
Skin Tears 1 1
Deformity/ Disfigurement 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Mar-01-2024
2 Synthes (USA) Products LLC II Dec-15-2020
3 T.A.G. MEDICAL PRODUCTS CORPORATION, LTD. II Mar-20-2020
4 Zimmer, Inc. II Feb-06-2023
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