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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DISTAL RADIUS PLATE, STANDARD, LEFT, 3 HOLES
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DISTAL RADIUS PLATE, STANDARD, LEFT, 3 HOLES Back to Search Results
Model Number FDR 011
Medical Device Problem Code Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 10/07/2021
Type of Reportable Event Malfunction
Event or Problem Description
The event included the implantation of a plate that had exceeded its shelf life.The shelf life on the packaging was indicated to be (b)(6) 2021.The plate was implanted on (b)(6) 2021.Therefore, the plate had been implanted 7 days after the expiration date.
 
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Brand Name
DISTAL RADIUS PLATE, STANDARD, LEFT, 3 HOLES
Common Device Name
DISTAL RADIUS PLATE
MDR Report Key12701092
Report Number3009996260-2021-00013
Device Sequence Number4550408
Product Code HRS
UDI-Device Identifier00840118109932
UDI-Public00840118109932
Combination Product (Y/N)N
Initial Reporter StatePA
Initial Reporter CountryUS
PMA/510(K) Number
K123562
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date09/30/2021
Device Model NumberFDR 011
Device Catalogue NumberFDR 011
Device Lot Number2014003004
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 10/07/2021
Initial Report FDA Received Date10/26/2021
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured10/30/2014
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
Patient Age62 YR
Patient Weight98
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