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	1
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	480	480
Break	84	84
Insufficient Information	55	55
Fracture	54	54
Mechanical Problem	34	34
Patient Device Interaction Problem	29	29
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	9
Inadequacy of Device Shape and/or Size	8	8
Unintended Movement	7	7
Naturally Worn	5	5
Entrapment of Device	5	5
Detachment of Device or Device Component	5	5
Loosening of Implant Not Related to Bone-Ingrowth	5	5
Mechanical Jam	4	4
Physical Resistance/Sticking	4	4
Packaging Problem	4	4
Loss of Osseointegration	3	3
Appropriate Term/Code Not Available	3	3
No Apparent Adverse Event	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Material Split, Cut or Torn	3	3
Device Slipped	3	3
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
Delivered as Unsterile Product	1	1
Shipping Damage or Problem	1	1
Difficult or Delayed Separation	1	1
Defective Device	1	1
Defective Component	1	1
Peeled/Delaminated	1	1
Crack	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	199
No Clinical Signs, Symptoms or Conditions	125	125
Injury	125	125
Bacterial Infection	72	72
Non-union Bone Fracture	47	47
Failure of Implant	36	36
Insufficient Information	35	35
Post Operative Wound Infection	31	31
Foreign Body In Patient	25	25
Pain	24	24
Nerve Damage	20	20
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
Skin Infection	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Osteomyelitis	10	10
Device Embedded In Tissue or Plaque	8	8
Perforation	8	8
Loss of Range of Motion	8	8
No Consequences Or Impact To Patient	6	6
Hematoma	6	6
Impaired Healing	5	5
Joint Contracture	5	5
Necrosis	4	4
Pulmonary Embolism	3	3
Scar Tissue	3	3
Thrombosis/Thrombus	3	3
Ossification	3	3
Inflammation	3	3
Tingling	3	3
Cellulitis	2	2
Localized Skin Lesion	2	2
Pseudoaneurysm	2	2
Tissue Breakdown	2	2
Wound Dehiscence	2	2
Ambulation Difficulties	2	2
Muscular Rigidity	1	1
Rupture	1	1
Swelling	1	1
Thrombosis	1	1
Hernia	1	1
No Patient Involvement	1	1
Unequal Limb Length	1	1
Implant Pain	1	1
Paresis	1	1
Sepsis	1	1
Abscess	1	1