TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BIOMET MICROFIXATION
	SUBSTANTIALLY EQUIVALENT	1
INDUSTRIAS MEDICAS SAMPEDRO S.A.S
	SUBSTANTIALLY EQUIVALENT	1
INION OY
	SUBSTANTIALLY EQUIVALENT	1
JEIL MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
KLS-MARTIN L.P.
	SUBSTANTIALLY EQUIVALENT	2
MEDCAD
	SUBSTANTIALLY EQUIVALENT	2
METICULY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICROWARE PRECISION CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SITES MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
SOUTHERN MEDICAL (PTY) , LTD.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CRANIOMAXILLOFACIAL
	SUBSTANTIALLY EQUIVALENT	1
STRYKER CRANIOMAXILLOFACIAL (CMF)
	SUBSTANTIALLY EQUIVALENT	1
STRYKER LEIBINGER GMBH & CO KG
	SUBSTANTIALLY EQUIVALENT	3
STRYKER LEIBINGER MICRO IMPLANTS
	SUBSTANTIALLY EQUIVALENT	1
TECHMAH CMF
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	1326	1331
Adverse Event Without Identified Device or Use Problem	611	620
Fracture	385	385
Device-Device Incompatibility	129	130
Material Twisted/Bent	121	121
Manufacturing, Packaging or Shipping Problem	120	120
Migration	99	102
Device Slipped	90	91
Device Contaminated During Manufacture or Shipping	73	73
Entrapment of Device	66	67
No Apparent Adverse Event	59	59
Material Deformation	46	46
Loosening of Implant Not Related to Bone-Ingrowth	41	44
Device Appears to Trigger Rejection	31	31
Crack	24	25
Osseointegration Problem	23	23
Difficult to Advance	20	20
Inadequacy of Device Shape and/or Size	18	18
Defective Device	18	21
Nonstandard Device	17	17
Loss of Osseointegration	15	15
Insufficient Information	14	14
Material Integrity Problem	14	14
Patient Device Interaction Problem	14	14
Device Damaged Prior to Use	13	13
Patient-Device Incompatibility	13	13
Material Fragmentation	12	12
Packaging Problem	11	11
Migration or Expulsion of Device	11	12
Failure to Cut	10	12
Use of Device Problem	10	10
Device Dislodged or Dislocated	9	9
Difficult to Insert	9	9
Malposition of Device	9	9
Material Discolored	8	8
Noise, Audible	8	8
Appropriate Term/Code Not Available	6	6
Detachment of Device or Device Component	5	5
Compatibility Problem	5	5
Improper or Incorrect Procedure or Method	5	5
Output Problem	5	5
Failure to Osseointegrate	4	4
Positioning Problem	4	4
Device Markings/Labelling Problem	4	4
Positioning Failure	3	3
Component Missing	3	3
Off-Label Use	3	3
Tear, Rip or Hole in Device Packaging	3	3
Naturally Worn	3	3
Mechanical Jam	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2026	2032
Insufficient Information	265	268
Unspecified Infection	202	205
Non-union Bone Fracture	127	130
Foreign Body In Patient	124	125
Failure of Implant	112	114
Pain	78	78
Swelling/ Edema	72	73
Unspecified Tissue Injury	71	72
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	67	68
Impaired Healing	55	55
Physical Asymmetry	42	44
Wound Dehiscence	33	33
Difficulty Chewing	27	27
Nerve Damage	27	27
Discomfort	26	27
Inflammation	26	26
Inadequate Osseointegration	23	23
Post Operative Wound Infection	23	23
Bacterial Infection	22	22
Confusion/ Disorientation	21	21
Hypersensitivity/Allergic reaction	18	19
Purulent Discharge	16	16
Skin Inflammation/ Irritation	15	17
Implant Pain	12	12
Bone Fracture(s)	12	12
Obstruction/Occlusion	11	11
Cerebrospinal Fluid Leakage	11	11
Paralysis	11	11
Paresthesia	10	10
Erythema	10	10
Fistula	10	10
Malunion of Bone	9	9
Necrosis	8	8
Visual Disturbances	8	8
Loss of Range of Motion	8	9
Hemorrhage/Bleeding	7	7
Hematoma	6	6
Deformity/ Disfigurement	6	6
Limited Mobility Of The Implanted Joint	6	6
Swelling	6	6
Headache	5	5
Foreign Body Reaction	5	5
Eye Pain	5	5
Local Reaction	4	6
Unspecified Musculoskeletal problem	4	4
Tinnitus	4	4
Joint Laxity	4	4
Osteolysis	4	4
Granuloma	4	4

Recalls
Manufacturer		Recall Class	Date Posted
1	Materialise N.V.	II	Aug-03-2023