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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device orthosis, cranial
Product CodeMVA
Regulation Number 882.5970
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED ORTHOPRO INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON BRACE INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
DANMAR PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EASTERN CRANIAL AFFILIATES, LLC
  SUBSTANTIALLY EQUIVALENT 1
HEADSTART, LTD.
  SUBSTANTIALLY EQUIVALENT 1
INVENT MEDICAL USA, LLC
  SUBSTANTIALLY EQUIVALENT 2
ORTHOMERICA PRODUCTS INC.
  SUBSTANTIALLY EQUIVALENT 1
ORTHOMERICA PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ORTHOTIC CARE SERVICES, LLP
  SUBSTANTIALLY EQUIVALENT 1
OTTO BOCK HEALTHCARE LP
  SUBSTANTIALLY EQUIVALENT 2
P-POD
  SUBSTANTIALLY EQUIVALENT 1
SYMBION LOGISTICS, LLC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2015 1 1
2016 1 1
2017 3 3
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2 2
Insufficient Information 1 1
Fitting Problem 1 1
Device Operates Differently Than Expected 1 1
Failure to Auto Stop 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Edema 1 1
Hematoma 1 1
Unspecified Infection 1 1
Scarring 1 1
Skin Discoloration 1 1
Swelling 1 1
Complaint, Ill-Defined 1 1
Injury 1 1
Post Operative Wound Infection 1 1
Fluid Discharge 1 1
No Known Impact Or Consequence To Patient 1 1

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