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	390	395
Break	337	339
Detachment of Device or Device Component	92	92
Fracture	67	67
Migration	35	38
Physical Resistance/Sticking	30	30
Device Dislodged or Dislocated	30	30
Device-Device Incompatibility	27	27
Manufacturing, Packaging or Shipping Problem	25	25
Difficult to Advance	21	21
Loosening of Implant Not Related to Bone-Ingrowth	19	20
Material Deformation	18	18
Patient Device Interaction Problem	13	13
Crack	12	12
Insufficient Information	8	8
Material Fragmentation	6	6
Material Twisted/Bent	6	6
Material Split, Cut or Torn	5	5
Unintended Movement	5	5
Mechanical Jam	4	4
Inaccurate Information	4	4
Entrapment of Device	4	4
Migration or Expulsion of Device	4	4
Device Damaged Prior to Use	4	4
Failure to Advance	4	4
Device Contaminated During Manufacture or Shipping	3	3
Loose or Intermittent Connection	3	3
Mechanical Problem	3	3
Connection Problem	3	3
Packaging Problem	3	3
Use of Device Problem	3	3
Firing Problem	2	2
Failure to Form Staple	2	2
Appropriate Term/Code Not Available	2	2
No Apparent Adverse Event	2	2
Material Separation	2	2
Device Damaged by Another Device	2	2
Component Missing	2	2
Material Integrity Problem	2	2
Patient-Device Incompatibility	2	2
Separation Failure	2	2
Activation Problem	2	2
Failure to Eject	2	2
Structural Problem	1	1
Difficult or Delayed Positioning	1	1
Delivered as Unsterile Product	1	1
Degraded	1	1
Contamination /Decontamination Problem	1	1
Defective Device	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	576	578
Non-union Bone Fracture	111	111
Insufficient Information	110	110
Pain	105	105
Implant Pain	54	59
Failure of Implant	35	35
Unspecified Tissue Injury	26	26
Foreign Body In Patient	25	25
Hypersensitivity/Allergic reaction	22	22
Bone Fracture(s)	22	22
Wound Dehiscence	21	21
Skin Inflammation/ Irritation	19	19
Perforation	19	19
Post Operative Wound Infection	17	17
Impaired Healing	16	16
Loss of Range of Motion	13	17
Unspecified Infection	12	12
Discomfort	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	10	10
Swelling/ Edema	10	10
Malunion of Bone	8	8
Foreign Body Reaction	7	7
Device Embedded In Tissue or Plaque	5	5
Cellulitis	5	5
Fall	4	4
Rupture	4	4
Synovitis	3	3
Cyst(s)	3	3
Osteolysis	3	3
Skin Infection	3	3
Arthritis	3	3
Post Traumatic Wound Infection	2	2
Inflammation	2	2
Numbness	2	2
Unspecified Musculoskeletal problem	2	2
Nerve Damage	2	2
Inadequate Osseointegration	2	3
Muscle/Tendon Damage	2	2
Joint Dislocation	2	2
Stroke/CVA	2	2
Physical Asymmetry	2	2
Ulcer	2	2
Erosion	2	2
Bacterial Infection	2	2
Ossification	1	1
Skin Discoloration	1	1
Itching Sensation	1	1
Seroma	1	1
Fever	1	1
Osteomyelitis	1	1

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