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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEXTREMITY SOLUTIONS STRATUM FOOT PLATING SYSTEM; BONE SCREW
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NEXTREMITY SOLUTIONS STRATUM FOOT PLATING SYSTEM; BONE SCREW Back to Search Results
Catalog Number STRM-NL-3550ST
Medical Device Problem Codes Labelling, Instructions for Use or Training Problem (1318); Device Markings/Labelling Problem (2911); Inaccurate Information (4051)
Health Effect - Clinical Code Not Applicable (3189)
Date of Event 09/18/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
 
Event or Problem Description
While building a stratum foot plating system set, a sales representative selected a screw labeled as strm-nl-3550st and noticed the product in the package did not match the information on the label.The screw in the package was visibly a shorter length and a different type of screw.
 
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Brand Name
STRATUM FOOT PLATING SYSTEM
Common Device Name
BONE SCREW
Manufacturer (Section D)
NEXTREMITY SOLUTIONS
210 north buffalo street
warsaw IN 46580
MDR Report Key9205308
Report Number3009540749-2019-00009
Device Sequence Number18908402
Product Code HWC
UDI-Device Identifier00817701022558
UDI-Public00817701022558
Combination Product (Y/N)N
Initial Reporter StateLA
Initial Reporter CountryUS
PMA/510(K) Number
K182201
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Non-Healthcare Professional
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 10/17/2019
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 Other
Device Expiration Date02/27/2024
Device Catalogue NumberSTRM-NL-3550ST
Device Lot NumberM1151
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/24/2019
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 09/18/2019
Initial Report FDA Received Date10/17/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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