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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLOWER ORTHOPEDICS MTP PLATE, LEFT
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FLOWER ORTHOPEDICS MTP PLATE, LEFT Back to Search Results
Model Number MFP 401
Medical Device Problem Code Fracture (1260)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 05/27/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Doctor implanted the plate such that the compression slot was placed over the joint and a compression screw was not used in the slot.This is not a recommended technique detailed in the accompanying surgical technique guide.
 
Event or Problem Description
The event included the fracturing of an implanted mtp plate at the compression slot after being implanted for 105 days.The affected hardware was able to be fully removed.
 
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Brand Name
MTP PLATE, LEFT
Common Device Name
MTP PLATE
Manufacturer (Section D)
FLOWER ORTHOPEDICS
100 witmer rd.
ste 280
horsham PA 19044
MDR Report Key12053329
Report Number3009996260-2021-00009
Device Sequence Number4411745
Product Code HRS
UDI-Device Identifier00840118111300
UDI-Public00840118111300
Combination Product (Y/N)N
Initial Reporter StateIN
Initial Reporter CountryUS
PMA/510(K) Number
K131657
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 distributor,health profession
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/23/2021
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 NumberMFP 401
Device Catalogue NumberMFP 401
Device Lot Number2008320848
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/16/2021
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 06/03/2021
Initial Report FDA Received Date06/23/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Other; Required Intervention;
Patient Age42 YR
Patient Weight79
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