TPLC - Total Product Life Cycle

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Device	staple, fixation, bone
Regulation Description	Single/multiple component metallic bone fixation appliances and accessories.
Product Code	JDR
Regulation Number	888.3030
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	422	427
Break	385	388
Detachment of Device or Device Component	109	109
Fracture	74	74
Migration	36	39
Device-Device Incompatibility	34	34
Physical Resistance/Sticking	33	33
Device Dislodged or Dislocated	31	31
Manufacturing, Packaging or Shipping Problem	28	28
Difficult to Advance	22	22
Crack	20	20
Material Deformation	18	18
Loosening of Implant Not Related to Bone-Ingrowth	18	19
Patient Device Interaction Problem	15	15
Appropriate Term/Code Not Available	13	13
Entrapment of Device	10	10
Migration or Expulsion of Device	8	8
Insufficient Information	8	8
Material Separation	7	7
Material Fragmentation	7	7
Material Twisted/Bent	6	6
Material Split, Cut or Torn	5	5
No Apparent Adverse Event	5	5
Unintended Movement	5	5
Mechanical Jam	4	4
Loose or Intermittent Connection	4	4
Inaccurate Information	4	4
Failure to Advance	4	4
Device Damaged Prior to Use	4	4
Corroded	3	3
Connection Problem	3	3
Packaging Problem	3	3
Difficult to Remove	3	3
Patient-Device Incompatibility	3	3
Mechanical Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Use of Device Problem	2	2
Component Missing	2	2
Failure to Align	2	2
Failure to Cut	2	2
Device Damaged by Another Device	2	2
Delivered as Unsterile Product	2	2
Material Integrity Problem	2	2
Defective Component	2	2
Separation Failure	2	2
Activation Problem	2	2
Failure to Eject	2	2
Failure to Form Staple	2	2
Firing Problem	2	2
Flaked	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	580	583
Pain	119	119
Insufficient Information	114	114
Non-union Bone Fracture	108	108
Implant Pain	54	59
No Consequences Or Impact To Patient	48	48
Failure of Implant	45	45
Injury	38	38
No Code Available	31	31
Foreign Body In Patient	28	28
Unspecified Tissue Injury	26	26
Bone Fracture(s)	25	25
Wound Dehiscence	24	24
Hypersensitivity/Allergic reaction	23	23
Post Operative Wound Infection	23	23
Impaired Healing	19	19
Perforation	17	17
Unspecified Infection	14	14
No Known Impact Or Consequence To Patient	14	14
Loss of Range of Motion	13	17
Skin Inflammation/ Irritation	13	13
Tissue Damage	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Discomfort	12	12
Not Applicable	11	11
Foreign Body Reaction	9	9
Malunion of Bone	8	8
No Patient Involvement	8	8
No Information	7	7
Cyst(s)	6	6
Swelling/ Edema	6	6
Cellulitis	5	5
Device Embedded In Tissue or Plaque	5	5
Rupture	4	4
Bacterial Infection	4	4
Abscess	4	4
Fall	4	4
Synovitis	3	3
Arthritis	3	3
Skin Infection	3	3
Osteolysis	3	3
Ulcer	2	2
Physical Asymmetry	2	2
Muscle/Tendon Damage	2	2
Erosion	2	2
Numbness	2	2
Swelling	2	2
Nerve Damage	2	2
Muscular Rigidity	2	2
Post Traumatic Wound Infection	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Biomet, Inc.	II	Mar-18-2022
2	Merete Medical GmbH	II	Feb-17-2022
3	Stryker GmbH	II	Nov-16-2020
4	Synthes (USA) Products LLC	II	Oct-18-2022
5	Synthes (USA) Products LLC	II	Oct-06-2022
6	Wright Medical Technology, Inc.	II	Mar-31-2022