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TPLC
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Device
spinal vertebral body replacement device - cervical
Definition
Vertebral body replacement in the cervical spine.
Product Code
PLR
Regulation Number
888.3060
Device Class
2
Premarket Reviews
Manufacturer
Decision
AESCULAP IMPLANTS SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
ASTURA MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
BRIGHT SPINE
SUBSTANTIALLY EQUIVALENT
2
CARDINAL SPINE, LLC
SUBSTANTIALLY EQUIVALENT
1
CMF MEDICON SURGICAL INC.
SUBSTANTIALLY EQUIVALENT
1
COLIGNE, AG
SUBSTANTIALLY EQUIVALENT
1
K2M, INC.
SUBSTANTIALLY EQUIVALENT
1
MEDOS INTERNATIONAL SARL
SUBSTANTIALLY EQUIVALENT
1
MIRUS, LLC
SUBSTANTIALLY EQUIVALENT
1
NEXXT SPINE LLC
SUBSTANTIALLY EQUIVALENT
1
NUVASIVE, INCORPORATED
SUBSTANTIALLY EQUIVALENT
2
OMNIA MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
1
STRYKER SPINE
SUBSTANTIALLY EQUIVALENT
1
ZAVATION MEDICAL PRODUCTS LLC
SUBSTANTIALLY EQUIVALENT
2
MDR Year
MDR Reports
MDR Events
2018
1
1
2019
1
1
2020
2
2
2021
4
4
2022
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Information
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Migration
2
2
Mechanics Altered
2
2
Device Misassembled During Manufacturing /Shipping
1
1
Activation Problem
1
1
Packaging Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
5
5
Dysphagia/ Odynophagia
2
2
Abdominal Pain
1
1
No Known Impact Or Consequence To Patient
1
1
Neck Pain
1
1
Pain
1
1
Swelling/ Edema
1
1
Arthritis
1
1
Respiratory Failure
1
1
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