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

MAUDE Adverse Event Report: LEVEL ONE CMF; PLATE
  • 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
 

LEVEL ONE CMF; PLATE Back to Search Results
Model Number 25-750-14-09
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Impaired Healing (2378)
Date of Event 10/21/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
An investigation was performed on the basis of complaint statistics as no device was returned for evaluation.The complaint percentage was calculated, and it is determined that the complaint percentage falls within the design risk limits adhered to at klm.During the investigation the product lot number was not identified; therefore, the device history records were not reviewed.The failure root cause cannot be determined due to the device not being returned.If further information is obtained that might add value to the contents of the investigation report, an additional follow-up report will be submitted.
 
Event or Problem Description
It was reported that a broken plate was identified using imaging, it was removed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
LEVEL ONE CMF
Common Device Name
PLATE
MDR Report Key12749009
Report Number9610905-2021-00106
Device Sequence Number4530783
Product Code MQN
UDI-Device Identifier00888118045492
UDI-Public(01)00888118045492
Combination Product (Y/N)N
Initial Reporter StateGA
Initial Reporter CountryUS
PMA/510(K) Number
K032442
Exemption Number2017029
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Model Number25-750-14-09
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/21/2021
Initial Report FDA Received Date11/03/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
Outcome Attributed to Adverse Event Other;
-
-