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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIMED INC SIDEWINDER PLATE, RT, 7-HOLE, MEDIUM

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TRIMED INC SIDEWINDER PLATE, RT, 7-HOLE, MEDIUM Back to Search Results
Model Number SWOR-7M
Device Problem Break (1069)
Patient Problems Fall (1848); Non-union Bone Fracture (2369)
Event Date 12/05/2021
Event Type  Injury  
Event Description
A trimed distributor from (b)(6), notified trimed on 05 dec 2021 that a swor-7m had broken and needed to be removed from the patient. The date believed to be the date of removal was (b)(6) 2021. It is currently believed that the break in the plate was caused by a nonunion, however additional information has been requested with no response yet. This device was implanted for approximately 3 months before the break was detected in an x-ray which prompted the removal of the device. It is currently believed that the patient has since started healing well, however additional information has been requested with no response yet. Additional information was requested on the following dates, 06 dec 2021, 09 dec 2021, 14 dec 2021, 16 dec 2021, 28 dec 2021 and 03 jan 2022, with no additional information provided as of 04 jan 2022.
 
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Brand NameSIDEWINDER PLATE, RT, 7-HOLE, MEDIUM
Type of DeviceSIDEWINDER PLATE, RT, 7-HOLE, MEDIUM
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 rissler
27533 avenue hopkins
santa clarita, CA 91355
MDR Report Key13322318
MDR Text Key289183829
Report Number2031009-2022-00001
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K060041
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 01/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/21/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSWOR-7M
Device Catalogue NumberSWOR-7M
Device Lot NumberMX20007
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? Yes
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: 01/21/2022 Patient Sequence Number: 1
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