TPLC - Total Product Life Cycle

• Device: orthosis, limb brace
• Product Code: IQI
• Regulation Number: 890.3475
• Device Class: 1

Premarket Reviews
Manufacturer	Decision
NEUROSPECTRUM LLC
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2014	39	39
2015	20	20
2016	14	14
2017	93	93
2018	19	19
2019	19	19
2020	11	11
2021	9	9
2022	11	11
2023	3	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	97	97
Adverse Event Without Identified Device or Use Problem	72	72
Detachment Of Device Component	12	12
Insufficient Information	10	10
Patient Device Interaction Problem	8	8
Device Operates Differently Than Expected	7	7
Break	4	4
Fungus in Device Environment	3	3
Inadequacy of Device Shape and/or Size	3	3
Device Packaging Compromised	3	3
Patient-Device Incompatibility	2	2
Device Markings/Labelling Problem	2	2
Mechanical Jam	2	2
Mechanics Altered	2	2
Unintended Collision	2	2
Peeled/Delaminated	1	1
Off-Label Use	1	1
Product Quality Problem	1	1
Material Rupture	1	1
Component Falling	1	1
Crack	1	1
Fracture	1	1
Gel Leak	1	1
Device Emits Odor	1	1
Device Slipped	1	1
Improper or Incorrect Procedure or Method	1	1
Fitting Problem	1	1
Component Missing	1	1
Structural Problem	1	1
Failure to Obtain Sample	1	1
Loss of or Failure to Bond	1	1
Human-Device Interface Problem	1	1
Manufacturing, Packaging or Shipping Problem	1	1
Material Integrity Problem	1	1
Material Protrusion/Extrusion	1	1
Sharp Edges	1	1
Device Fell	1	1
Positioning Problem	1	1
Scratched Material	1	1
Therapeutic or Diagnostic Output Failure	1	1
Torn Material	1	1
No Apparent Adverse Event	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Known Impact Or Consequence To Patient	75	75
No Consequences Or Impact To Patient	31	31
Itching Sensation	22	22
Skin Irritation	17	17
Rash	14	14
Erythema	14	14
Irritation	11	11
Pain	10	10
Swelling	9	9
Fall	9	9
Skin Inflammation/ Irritation	8	8
Injury	6	6
Bone Fracture(s)	6	6
Unspecified Infection	5	5
Laceration(s)	5	5
No Patient Involvement	5	5
Numbness	4	4
Pressure Sores	3	3
Blister	3	3
No Information	3	3
Hypersensitivity/Allergic reaction	3	3
Abrasion	3	3
Cellulitis	3	3
Bacterial Infection	2	2
Bruise/Contusion	2	2
Burn(s)	2	2
Inflammation	2	2
Damage to Ligament(s)	2	2
Thrombosis	2	2
Nerve Damage	2	2
Sprain	2	2
No Code Available	2	2
Joint Dislocation	2	2
Reaction	2	2
Ambulation Difficulties	2	2
Discomfort	2	2
Ulceration	2	2
Burning Sensation	2	2
Rupture	2	2
Fungal Infection	2	2
Insufficient Information	2	2
No Clinical Signs, Symptoms or Conditions	2	2
Patient Problem/Medical Problem	2	2
Limited Mobility Of The Implanted Joint	1	1
Fluid Discharge	1	1
Post Operative Wound Infection	1	1
Suture Abrasion	1	1
Skin Tears	1	1
Arthralgia	1	1
Deformity/ Disfigurement	1	1
Joint Disorder	1	1
Infection, Indirect	1	1
Ulcer	1	1
Complaint, Ill-Defined	1	1
Caustic/Chemical Burns	1	1
Limb Fracture	1	1
Muscle/Tendon Damage	1	1
Skin Burning Sensation	1	1
Localized Skin Lesion	1	1
Skin Infection	1	1
Contact Dermatitis	1	1
Unspecified Tissue Injury	1	1
Swelling/ Edema	1	1
Tissue Damage	1	1
Local Reaction	1	1
Skin Discoloration	1	1
Spinal Column Injury	1	1
Muscle Weakness	1	1
Necrosis	1	1
Phlebitis	1	1
Loss of Range of Motion	1	1
Wound Dehiscence	1	1
Failure of Implant	1	1
Hematoma	1	1
Hemorrhage/Bleeding	1	1
Arthritis	1	1
Asthma	1	1
Cyst(s)	1	1
Death	1	1
Purulent Discharge	1	1
Emotional Changes	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	3M Company - Health Care Business	II	Mar-09-2018
2	Breg Inc	II	Apr-10-2014
3	DeRoyal Industries Inc	II	Dec-06-2016
4	Ossur H / F	II	Mar-31-2016
5	Townsend Design	II	Jan-05-2024
6	United Surgical Associates	II	May-23-2015