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	429	434
Break	396	399
Detachment of Device or Device Component	109	109
Fracture	75	75
Migration	36	39
Device-Device Incompatibility	34	34
Physical Resistance/Sticking	34	34
Device Dislodged or Dislocated	31	31
Manufacturing, Packaging or Shipping Problem	28	28
Difficult to Advance	22	22
Loosening of Implant Not Related to Bone-Ingrowth	20	21
Crack	20	20
Material Deformation	18	18
Patient Device Interaction Problem	15	15
Appropriate Term/Code Not Available	13	13
Entrapment of Device	10	10
Insufficient Information	9	9
Material Separation	8	8
Migration or Expulsion of Device	8	8
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
Failure to Advance	4	4
Device Damaged Prior to Use	4	4
Inaccurate Information	4	4
Loose or Intermittent Connection	4	4
Mechanical Jam	4	4
Patient-Device Incompatibility	3	3
Difficult to Remove	3	3
Connection Problem	3	3
Mechanical Problem	3	3
Corroded	3	3
Packaging Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Failure to Form Staple	2	2
Firing Problem	2	2
Flaked	2	2
Delivered as Unsterile Product	2	2
Device Damaged by Another Device	2	2
Failure to Cut	2	2
Failure to Align	2	2
Component Missing	2	2
Use of Device Problem	2	2
Material Integrity Problem	2	2
Defective Component	2	2
Separation Failure	2	2
Activation Problem	2	2
Failure to Eject	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	588	591
Pain	127	127
Non-union Bone Fracture	119	119
Insufficient Information	115	115
Implant Pain	54	59
No Consequences Or Impact To Patient	48	48
Failure of Implant	46	46
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