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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE STRYDE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number STP5-400
Medical Device Problem Code Migration or Expulsion of Device (1395)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 10/09/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No product has been returned for evaluation.Radiographs provided confirmed the alleged event.No root cause can be confirmed at this time.
 
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2019.As per reporter, the patient reported protruding skin.Reportedly, the proximal tibia screw was loose and backing out two months post surgery.
 
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Brand Name
PRECICE STRYDE SYSTEM
Common Device Name
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
NUVASIVE SPECIALIZED ORTHOPEDICS, INC.
101 enterprise
suite 100
aliso viejo CA 92656
MDR Report Key9196877
Report Number3006179046-2019-00165
Device Sequence Number16245643
Product Code HSB
UDI-Device Identifier00887517952769
UDI-Public887517952769
Combination Product (Y/N)N
Initial Reporter CountrySN
PMA/510(K) Number
K180503
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberSTP5-400
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/07/2019
Initial Report FDA Received Date10/16/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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