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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, posterior spinal elements
Definition This device is a non-fusion, load-bearing implanted prosthesis that stabilizes the spine following resection of posterior spinal elements.
Product CodeQWK
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 0 0 4 1 5

MDR Year MDR Reports MDR Events
2023 3 3
2024 28 28
2025 9 9

Device Problems MDRs with this Device Problem Events in those MDRs
Device Appears to Trigger Rejection 18 18
Adverse Event Without Identified Device or Use Problem 7 7
Solder Joint Fracture 4 4
Improper or Incorrect Procedure or Method 3 3
Insufficient Information 2 2
Material Split, Cut or Torn 1 1
Accessory Incompatible 1 1
Defective Component 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Naturally Worn 1 1
Loose or Intermittent Connection 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Implant Pain 19 19
Insufficient Information 7 7
Pain 7 7
No Clinical Signs, Symptoms or Conditions 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Bacterial Infection 1 1
Inadequate Pain Relief 1 1

Recalls
Manufacturer Recall Class Date Posted
1 PREMIA SPINE LTD II Sep-04-2025
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