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
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	1163	1168
Adverse Event Without Identified Device or Use Problem	563	572
Fracture	353	353
Device-Device Incompatibility	125	126
Manufacturing, Packaging or Shipping Problem	116	116
Material Twisted/Bent	115	115
Migration	98	101
Device Slipped	80	81
Device Contaminated During Manufacture or Shipping	73	73
Entrapment of Device	63	64
No Apparent Adverse Event	56	56
Material Deformation	42	42
Loosening of Implant Not Related to Bone-Ingrowth	39	42
Device Appears to Trigger Rejection	22	22
Osseointegration Problem	21	21
Crack	20	21
Difficult to Advance	20	20
Defective Device	18	21
Nonstandard Device	16	16
Inadequacy of Device Shape and/or Size	16	16
Insufficient Information	14	14
Patient Device Interaction Problem	14	14
Loss of Osseointegration	13	13
Device Damaged Prior to Use	13	13
Material Integrity Problem	13	13
Material Fragmentation	12	12
Patient-Device Incompatibility	11	11
Packaging Problem	11	11
Migration or Expulsion of Device	11	12
Failure to Cut	10	12
Use of Device Problem	10	10
Malposition of Device	9	9
Material Discolored	8	8
Difficult to Insert	8	8
Device Dislodged or Dislocated	8	8
Noise, Audible	8	8
Appropriate Term/Code Not Available	6	6
Output Problem	5	5
Failure to Osseointegrate	4	4
Positioning Problem	4	4
Detachment of Device or Device Component	4	4
Device Markings/Labelling Problem	4	4
Improper or Incorrect Procedure or Method	4	4
Positioning Failure	3	3
Component Missing	3	3
Tear, Rip or Hole in Device Packaging	3	3
Naturally Worn	3	3
Mechanical Jam	3	3
Off-Label Use	2	2
Difficult or Delayed Positioning	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1823	1829
Insufficient Information	225	228
Unspecified Infection	169	172
Non-union Bone Fracture	121	124
Foreign Body In Patient	118	119
Failure of Implant	112	114
Pain	72	72
Swelling/ Edema	71	72
Unspecified Tissue Injury	70	71
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	67	68
Impaired Healing	52	52
Physical Asymmetry	38	40
Wound Dehiscence	32	32
Inflammation	26	26
Discomfort	25	26
Nerve Damage	25	25
Difficulty Chewing	23	23
Inadequate Osseointegration	22	22
Bacterial Infection	21	21
Confusion/ Disorientation	21	21
Post Operative Wound Infection	19	19
Hypersensitivity/Allergic reaction	18	19
Purulent Discharge	16	16
Skin Inflammation/ Irritation	15	17
Bone Fracture(s)	12	12
Implant Pain	12	12
Obstruction/Occlusion	11	11
Paralysis	11	11
Cerebrospinal Fluid Leakage	10	10
Erythema	10	10
Paresthesia	10	10
Loss of Range of Motion	8	9
Visual Disturbances	8	8
Fistula	7	7
Malunion of Bone	7	7
Swelling	6	6
Deformity/ Disfigurement	6	6
Hematoma	6	6
Necrosis	6	6
Limited Mobility Of The Implanted Joint	6	6
Foreign Body Reaction	5	5
Eye Pain	5	5
Tinnitus	4	4
Hemorrhage/Bleeding	4	4
Local Reaction	4	6
Osteolysis	4	4
Headache	4	4
Granuloma	4	4
Unspecified Musculoskeletal problem	3	3
Erosion	3	3

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