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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device table, surgical with orthopedic accessories, ac-powered
Product CodeJEA
Regulation Number 878.4960
Device Class 1

MDR Year MDR Reports MDR Events
2019 63 63
2020 46 46
2021 40 40
2022 32 32
2023 34 34
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended Movement 53 53
Insufficient Information 27 27
Adverse Event Without Identified Device or Use Problem 23 23
Use of Device Problem 22 22
Unintended System Motion 15 15
Device Slipped 15 15
Improper or Incorrect Procedure or Method 12 12
Device Fell 11 11
Unexpected Shutdown 11 11
Mechanical Problem 9 9
Detachment of Device or Device Component 8 8
Device Dislodged or Dislocated 8 8
Electrical Shorting 6 6
Fracture 5 5
Positioning Problem 5 5
Device Handling Problem 4 4
Loss of or Failure to Bond 4 4
Crack 4 4
Patient-Device Incompatibility 4 4
Smoking 3 3
Break 3 3
Misassembly by Users 3 3
No Apparent Adverse Event 3 3
Output Problem 3 3
Communication or Transmission Problem 2 2
Patient Device Interaction Problem 2 2
Malposition of Device 2 2
Circuit Failure 2 2
Intermittent Continuity 2 2
Inadequate Instructions for Healthcare Professional 2 2
Loose or Intermittent Connection 2 2
Positioning Failure 2 2
Electrical /Electronic Property Problem 2 2
Overheating of Device 2 2
Corroded 2 2
Unintended Collision 2 2
Material Separation 1 1
Defective Component 1 1
Component Missing 1 1
Structural Problem 1 1
Application Program Problem 1 1
Battery Problem 1 1
Mechanical Jam 1 1
Entrapment of Device 1 1
Fire 1 1
Disconnection 1 1
Misconnection 1 1
Moisture Damage 1 1
Use of Incorrect Control/Treatment Settings 1 1
Degraded 1 1
Collapse 1 1
Computer Software Problem 1 1
Failure to Clean Adequately 1 1
Key or Button Unresponsive/not Working 1 1
Unintended Electrical Shock 1 1
Physical Resistance/Sticking 1 1
Noise, Audible 1 1
Wireless Communication Problem 1 1
Connection Problem 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 69 69
No Known Impact Or Consequence To Patient 52 52
Fall 44 44
Insufficient Information 18 18
Pressure Sores 11 11
No Consequences Or Impact To Patient 10 10
Erythema 6 6
Injury 5 5
Skin Tears 5 5
Laceration(s) 5 5
Pain 4 4
Bone Fracture(s) 4 4
Bruise/Contusion 4 4
No Patient Involvement 3 3
Abrasion 3 3
Unintended Extubation 3 3
Muscle/Tendon Damage 2 2
No Information 2 2
Swelling 2 2
Stenosis 2 2
Numbness 2 2
Burn(s) 2 2
Hematoma 2 2
Paralysis 2 2
Damage to Ligament(s) 2 2
Muscle Weakness 1 1
Necrosis 1 1
Nerve Damage 1 1
Perforation 1 1
Skin Irritation 1 1
Hemorrhage, Subarachnoid 1 1
Low Blood Pressure/ Hypotension 1 1
Incontinence 1 1
Irritation 1 1
Cardiac Arrest 1 1
Contusion 1 1
Spinal Cord Injury 1 1
Paraplegia 1 1
Low Oxygen Saturation 1 1
Tissue Breakdown 1 1
Ambulation Difficulties 1 1
Electric Shock 1 1
Extubate 1 1
Concussion 1 1
Arrhythmia 1 1
Bacterial Infection 1 1
No Code Available 1 1
Respiratory Insufficiency 1 1
Limb Fracture 1 1
Vertebral Fracture 1 1
Blister 1 1
Swelling/ Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Mizuho OSI II Oct-09-2020
2 Steris Corporation II Feb-24-2021
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