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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS, INC. STRATUM FPS PLATE

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NEXTREMITY SOLUTIONS, INC. STRATUM FPS PLATE Back to Search Results
Catalog Number STRM-ST8-RS
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2021
Event Type  malfunction  
Manufacturer Narrative
If addtional information is provided that changes the outcome of the investigation, a follow-up report will be filed.
 
Event Description
Surgeon selected a stratum rs 8 hole plate strm-st8-rs. After placing the plate down on the foot he realized that the plate was to long for desired repair. While attempting to remove the plate one of the tines broke off. Surgeon decided to leave it in patient.
 
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Brand NameSTRATUM FPS
Type of DevicePLATE
Manufacturer (Section D)
NEXTREMITY SOLUTIONS, INC.
1195 polk drive
warsaw IN 46582
Manufacturer (Section G)
NEXTREMITY SOLUTIONS, INC.
1195 polk drive
warsaw IN 46582
Manufacturer Contact
travis christman
1195 polk drive
warsaw, IN 46582
MDR Report Key12915258
MDR Text Key281609945
Report Number3009540749-2021-00039
Device Sequence Number1
Product Code HRS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200785
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberSTRM-ST8-RS
Device Lot Number154667
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/02/2021
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 Unkown

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