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
Break	341	341
Adverse Event Without Identified Device or Use Problem	249	253
Detachment of Device or Device Component	104	104
Fracture	65	65
Device-Device Incompatibility	34	34
Migration	33	36
Device Dislodged or Dislocated	31	31
Manufacturing, Packaging or Shipping Problem	28	28
Physical Resistance/Sticking	26	26
Difficult to Advance	22	22
Crack	20	20
Patient Device Interaction Problem	14	14
Appropriate Term/Code Not Available	13	13
Loosening of Implant Not Related to Bone-Ingrowth	13	13
Material Deformation	10	10
Entrapment of Device	9	9
Migration or Expulsion of Device	8	8
Material Separation	7	7
Insufficient Information	7	7
Material Twisted/Bent	6	6
Material Fragmentation	6	6
Material Split, Cut or Torn	5	5
Mechanical Jam	4	4
Loose or Intermittent Connection	4	4
Inaccurate Information	4	4
No Apparent Adverse Event	4	4
Corroded	3	3
Connection Problem	3	3
Packaging Problem	3	3
Difficult to Remove	3	3
Device Contaminated During Manufacture or Shipping	3	3
Unintended Movement	3	3
Patient-Device Incompatibility	3	3
Device Damaged Prior to Use	3	3
Fitting Problem	2	2
Use of Device Problem	2	2
Component Missing	2	2
Failure to Align	2	2
Flaked	2	2
Firing Problem	2	2
Failure to Cut	2	2
Device Damaged by Another Device	2	2
Material Integrity Problem	2	2
Defective Component	2	2
Separation Failure	2	2
Activation Problem	2	2
Failure to Advance	2	2
Failure to Eject	2	2
Mechanical Problem	2	2
Failure to Form Staple	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	524	524
Non-union Bone Fracture	80	80
Pain	79	79
Insufficient Information	60	60
No Consequences Or Impact To Patient	48	48
Failure of Implant	40	40
Injury	38	38
No Code Available	31	31
Unspecified Tissue Injury	26	26
Foreign Body In Patient	25	25
Hypersensitivity/Allergic reaction	20	20
Bone Fracture(s)	20	20
Post Operative Wound Infection	19	19
Perforation	17	17
Impaired Healing	14	14
No Known Impact Or Consequence To Patient	14	14
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Tissue Damage	12	12
Implant Pain	12	16
Loss of Range of Motion	12	15
Unspecified Infection	11	11
Not Applicable	11	11
Discomfort	11	11
Skin Inflammation/ Irritation	10	10
No Patient Involvement	8	8
Wound Dehiscence	7	7
No Information	7	7
Foreign Body Reaction	7	7
Malunion of Bone	6	6
Swelling/ Edema	5	5
Cellulitis	5	5
Device Embedded In Tissue or Plaque	4	4
Abscess	4	4
Rupture	4	4
Cyst(s)	4	4
Osteolysis	3	3
Synovitis	3	3
Fall	3	3
Arthritis	3	3
Skin Infection	3	3
Muscular Rigidity	2	2
Nerve Damage	2	2
Swelling	2	2
Numbness	2	2
Inflammation	2	2
Unspecified Musculoskeletal problem	2	2
Muscle/Tendon Damage	2	2
Joint Dislocation	2	2
Stroke/CVA	2	2
Ulcer	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