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 instrument, surgical, orthopedic, pneumatic powered & accessory/attachment
Regulation Description Surgical instrument motors and accessories/attachments.
Product CodeHSZ
Regulation Number 878.4820
Device Class 1

MDR Year MDR Reports MDR Events
2021 27 27
2022 35 36
2023 39 39
2024 7 7
2025 4 4
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 64 65
Failure to Cut 24 24
Entrapment of Device 16 16
Overheating of Device 6 6
Device-Device Incompatibility 5 5
Excessive Heating 3 3
Material Rupture 2 2
Material Deformation 2 2
Leak/Splash 1 1
Expulsion 1 1
Physical Resistance/Sticking 1 1
Unintended Movement 1 1
Defective Device 1 1
Material Integrity Problem 1 1
Difficult to Remove 1 1
Contamination /Decontamination Problem 1 1
Unintended Ejection 1 1
Adverse Event Without Identified Device or Use Problem 1 1
No Apparent Adverse Event 1 1
Power Problem 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 89 90
Foreign Body In Patient 15 15
Insufficient Information 6 6
Superficial (First Degree) Burn 2 2
Abrasion 1 1
Burn(s) 1 1
Foreign Body Reaction 1 1
Hearing Impairment 1 1
Unspecified Infection 1 1
Laceration(s) 1 1
Pain 1 1
Tinnitus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Synthes (USA) Products LLC II Mar-01-2024
-
-