Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device awl
Regulation Description Orthopedic manual surgical instrument.
Product CodeHWJ
Regulation Number 888.4540
Device Class 1

MDR Year MDR Reports MDR Events
2020 9 9
2021 9 9
2022 10 10
2023 9 9
2024 17 17
2025 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Break 45 45
Material Deformation 8 8
Failure to Cut 7 7
Contamination /Decontamination Problem 5 5
Material Twisted/Bent 4 4
Entrapment of Device 3 3
Degraded 2 2
Fracture 2 2
Naturally Worn 2 2
Dull, Blunt 2 2
Device Contaminated During Manufacture or Shipping 1 1
Mechanical Problem 1 1
Material Integrity Problem 1 1
Scratched Material 1 1
Delivered as Unsterile Product 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 49 49
Insufficient Information 9 9
Foreign Body In Patient 4 4
No Consequences Or Impact To Patient 3 3
No Code Available 2 2
Injury 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Decreased Sensitivity 1 1
Fatigue 1 1
Weakness 1 1
No Patient Involvement 1 1
Nerve Damage 1 1
Paresis 1 1
Unspecified Tissue Injury 1 1
Hypoesthesia 1 1
Deformity/ Disfigurement 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Alphatec Spine, Inc. II Aug-28-2023
2 K2M, Inc II Apr-24-2020
3 SEASPINE ORTHOPEDICS CORPORATION II Jul-15-2024
-
-