TPLC - Total Product Life Cycle

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Device	apparatus, traction, non-powered
Regulation Description	Nonpowered orthopedic traction apparatus and accessories.
Product Code	HST
Regulation Number	888.5850
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	43	43
Device-Device Incompatibility	20	20
Unintended Movement	19	19
Patient Device Interaction Problem	10	10
Detachment of Device or Device Component	9	9
Unstable	8	8
Defective Device	8	8
Physical Resistance/Sticking	7	7
Use of Device Problem	6	6
Adverse Event Without Identified Device or Use Problem	6	6
Insufficient Information	5	5
Positioning Failure	5	5
Mechanical Jam	5	5
Mechanical Problem	4	4
Manufacturing, Packaging or Shipping Problem	3	3
Material Twisted/Bent	3	3
Material Deformation	3	3
Naturally Worn	3	3
Fitting Problem	2	2
Device Markings/Labelling Problem	2	2
Therapeutic or Diagnostic Output Failure	2	2
Component Missing	2	2
Device Dislodged or Dislocated	2	2
Material Frayed	1	1
Device Alarm System	1	1
Device Fell	1	1
Contamination /Decontamination Problem	1	1
Material Fragmentation	1	1
Device Difficult to Setup or Prepare	1	1
Device Unsafe to Use in Environment	1	1
Electromagnetic Compatibility Problem	1	1
Retraction Problem	1	1
Device Contamination with Chemical or Other Material	1	1
Activation Failure	1	1
Inadequate or Insufficient Training	1	1
Connection Problem	1	1
Difficult to Open or Close	1	1
Corroded	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	144	144
Insufficient Information	13	13
Bone Fracture(s)	6	6
Nerve Damage	3	3
Hip Fracture	2	2
Laceration(s)	2	2
Pain	2	2
Foreign Body In Patient	1	1
Muscle/Tendon Damage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Mar-20-2024