TPLC - Total Product Life Cycle

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Device	pin, fixation, threaded
Regulation Description	Smooth or threaded metallic bone fixation fastener.
Product Code	JDW
Regulation Number	888.3040
Device Class	2

Premarket Reviews
Manufacturer	Decision
BIODYNAMIK, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDULOC, LLC
	SUBSTANTIALLY EQUIVALENT	1
SMITH & NEPHEW, INC.
	SUBSTANTIALLY EQUIVALENT	3
STRYKER GMBH
	SUBSTANTIALLY EQUIVALENT	1
SYNTEC SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
TINAVI (ANHUI) MEDICAL TECHNOLOGIES CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	481	492
Break	85	85
Fracture	56	56
Insufficient Device Problem Information	55	55
Mechanical Problem	34	34
Patient Device Interaction Problem	34	34
Device Markings/Labelling Problem	22	22
Material Deformation	19	19
Material Fragmentation	17	17
Migration	13	13
Device-Device Incompatibility	11	11
Loose or Intermittent Connection	9	9
Device Dislodged or Dislocated	9	10
Inadequacy of Device Shape and/or Size	8	8
Unintended Movement	7	7
Entrapment of Device	6	6
Naturally Worn	5	5
Loosening of Implant Not Related to Bone-Ingrowth	5	5
Mechanical Jam	4	5
Physical Resistance/Sticking	4	4
Packaging Problem	4	4
Loss of Osseointegration	3	3
Appropriate Device Problem Term/Code Not Available	3	3
No Apparent Adverse Event	3	3
Detachment of Device or Device Component	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Material Split, Cut or Torn	3	3
Device Slipped	3	3
Delivered as Unsterile Product	2	2
Contamination /Decontamination Problem	2	2
Separation Failure	2	2
Protective Measures Problem	2	2
Device Contaminated During Manufacture or Shipping	2	2
Material Twisted/Bent	1	1
Mechanics Altered	1	1
Use of Device Problem	1	1
Difficult or Delayed Separation	1	1
Device Damaged Prior to Receipt by User	1	1
Defective Device	1	1
Defective Component	1	1
Peeled/Delaminated	1	1
Crack	1	1
Incomplete or Missing Packaging	1	1
Nonstandard Device	1	1
Connection Problem	1	1
Human-Device Interface Problem	1	1
Self-Activation or Keying	1	1
Corroded	1	1
Activation, Positioning or Separation Problem	1	1
Fitting Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	199	208
No Clinical Signs, Symptoms or Conditions	128	129
Injury	125	125
Bacterial Infection	77	77
Nonunion/Delayed-union Bone Fracture	47	47
Failure of Implant	40	41
Insufficient Information	37	38
Post Operative Wound Infection	31	31
Foreign Body In Patient	26	26
Pain	24	24
Nerve Damage	20	22
Deformity/ Disfigurement	19	19
No Code Available	19	19
Malunion of Bone	17	17
Bone Fracture(s)	13	13
No Known Impact Or Consequence To Patient	13	13
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	11	11
Skin Infection	11	11
Osteomyelitis	10	11
Perforation	8	8
Medical device site infection	8	8
Device Embedded In Tissue or Plaque	8	8
Loss of Range of Motion	8	8
Hematoma	6	6
No Consequences Or Impact To Patient	6	6
Joint Contracture	5	5
Impaired Healing	5	5
Necrosis	4	4
Inflammation	3	4
Extraskeletal ossification	3	3
Pulmonary Embolism	3	3
Thrombosis/Thrombus	3	3
Tingling	3	3
Scar Tissue	3	3
Tissue Breakdown	2	2
Localized Skin Lesion	2	2
Cellulitis	2	2
Ambulation or Postural Difficulties	2	2
Wound Dehiscence	2	2
Pseudoaneurysm	2	2
Granuloma	1	1
Arthritis	1	1
Fibrosis	1	1
Swollen Lymph Nodes/Glands	1	1
External Prosthetic Device Pain	1	1
Ulcer	1	1
Aneurysm	1	1
Swelling/ Edema	1	1
Unspecified Tissue Injury	1	1
Joint Laxity	1	1