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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS STRATUM FOOT PLATING SYSTEM; PLATE
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NEXTREMITY SOLUTIONS STRATUM FOOT PLATING SYSTEM; PLATE Back to Search Results
Catalog Number STRM-LAP-SMR
Medical Device Problem Code Inaccurate Information (4051)
Health Effect - Clinical Code No Known Impact Or Consequence To Patient (2692)
Date of Event 11/25/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available at the time of the initial report, a follow-up report will be filed as appropriate.
 
Event or Problem Description
It was reported that a stratum foot plating system strm-lap-smr (stratum lapidus plate - small rt) package was opened and found to contain a strm-lap-sml (stratum lapidus plate - small lt).The surgeon selected an alternate plate to complete the surgery.There were no patient complications reported.
 
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Brand Name
STRATUM FOOT PLATING SYSTEM
Common Device Name
PLATE
Manufacturer (Section D)
NEXTREMITY SOLUTIONS
210 north buffalo street
warsaw IN 46580
MDR Report Key9505713
Report Number3009540749-2019-00024
Device Sequence Number13922840
Product Code HRS
UDI-Device Identifier00817701025467
UDI-Public00817701025467
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K182201
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 12/20/2019
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 Date08/04/2019
Device Catalogue NumberSTRM-LAP-SMR
Device Lot NumberM1502
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/25/2019
Initial Report FDA Received Date12/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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