TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
EISERTECH, 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	883	883
Break	102	102
Insufficient Information	80	80
Fracture	56	56
Migration	44	44
Mechanical Problem	43	43
Patient Device Interaction Problem	33	33
Device Markings/Labelling Problem	23	23
Material Deformation	20	20
Material Fragmentation	18	18
Appropriate Term/Code Not Available	17	17
Loose or Intermittent Connection	15	15
Patient-Device Incompatibility	15	15
Malposition of Device	14	14
Device-Device Incompatibility	11	11
Device Dislodged or Dislocated	11	11
Loosening of Implant Not Related to Bone-Ingrowth	11	11
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
Mechanical Jam	4	4
Physical Resistance/Sticking	4	4
Packaging Problem	4	4
Loss of Osseointegration	3	3
No Apparent Adverse Event	3	3
Contamination /Decontamination Problem	3	3
Manufacturing, Packaging or Shipping Problem	3	3
Defective Component	3	3
Material Split, Cut or Torn	3	3
Device Slipped	3	3
Material Twisted/Bent	2	2
Separation Failure	2	2
Protective Measures Problem	2	2
Human-Device Interface Problem	2	2
Device Contaminated During Manufacture or Shipping	2	2
Shipping Damage or Problem	1	1
Mechanics Altered	1	1
Difficult to Remove	1	1
Delivered as Unsterile Product	1	1
Difficult or Delayed Separation	1	1
Defective Device	1	1
Peeled/Delaminated	1	1
Crack	1	1
Activation, Positioning or Separation Problem	1	1
Nonstandard Device	1	1
Connection Problem	1	1
Self-Activation or Keying	1	1
Fitting Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Unspecified Infection	475	475
Injury	193	193
Post Operative Wound Infection	121	121
No Clinical Signs, Symptoms or Conditions	119	119
Bacterial Infection	76	76
No Code Available	73	73
No Known Impact Or Consequence To Patient	73	73
Non-union Bone Fracture	59	59
Inflammation	53	53
No Information	51	51
Pain	40	40
Failure of Implant	39	39
Insufficient Information	37	37
Foreign Body In Patient	25	25
Erythema	24	24
Nerve Damage	23	23
Bone Fracture(s)	22	22
Deformity/ Disfigurement	20	20
No Consequences Or Impact To Patient	18	18
Loss of Range of Motion	14	14
Device Embedded In Tissue or Plaque	12	12
Malunion of Bone	12	12
Irritation	12	12
Impaired Healing	11	11
Skin Infection	11	11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	11	11
Perforation	11	11
Osteomyelitis	10	10
Thrombosis	9	9
Swelling	9	9
Tissue Breakdown	7	7
Purulent Discharge	6	6
Hematoma	6	6
Arthritis	6	6
Discharge	6	6
Tissue Damage	6	6
Cellulitis	5	5
Ossification	5	5
Ambulation Difficulties	5	5
Fluid Discharge	5	5
Hemorrhage/Bleeding	5	5
Joint Contracture	5	5
Necrosis	4	4
Pulmonary Embolism	4	4
Joint Dislocation	4	4
Fall	4	4
Abscess	4	4
Thrombosis/Thrombus	3	3
Scar Tissue	3	3
Tingling	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Orthofix Srl	II	Nov-14-2019