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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIMED INC 1ST MTP 0 DEGREE DORSIFLEXED,LT,9-HOLE

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TRIMED INC 1ST MTP 0 DEGREE DORSIFLEXED,LT,9-HOLE Back to Search Results
Model Number MTPL-9
Device Problem Fracture (1260)
Patient Problem Insufficient Information (4580)
Event Date 03/15/2022
Event Type  malfunction  
Event Description
A trimed sales representative reported on (b)(6) 2022 that a mtpl-9 had broken in the patient. It was stated that the surgeon had a (b)(6) patient who had a previously failed toe implant (not a trimed product), the surgeon removed the silastic implant and put an allograft bone wedge in and plated with the mtpl-9. It was stated by the sales rep and surgeon that the fracture looked fused and was doing well when there was a sudden onset of pain 3 months post surgery (initial surgery date unknown), it was also mentioned that the patient typically has surgery complications. Lastly, it was stated that the surgeon plans to remove the hardware, the surgery date is currently unknown. The surgeon does not believe that this issue will cause any lasting issues in the patient.
 
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Brand Name1ST MTP 0 DEGREE DORSIFLEXED,LT,9-HOLE
Type of Device1ST MTP 0 DEGREE DORSIFLEXED,LT,9-HOLE
Manufacturer (Section D)
TRIMED INC
27533 avenue hopkins
santa clarita CA 91355
Manufacturer (Section G)
TRIMED INC
27533 avenue hopkins
santa clarita CA 91355
Manufacturer Contact
stephanie miranda
27533 avenue hopkins
santa clarita, CA 91355
MDR Report Key14084240
MDR Text Key291358390
Report Number2031009-2022-00002
Device Sequence Number1
Product Code HRS
UDI-Device Identifier00842188119989
UDI-Public00842188119989
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K192696
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMTPL-9
Device Catalogue NumberMTPL-9
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/12/2022 Patient Sequence Number: 1
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