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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 PS10.0-80SJ265
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event Serious Injury
Event or Problem Description
Information was received that the nail preconsolidated.The nail was removed on an unknown date.
 
Additional Manufacturer Narrative
The device has not been returned for evaluation.The root cause is unable to be determined at this time.If any additional information is provided, a supplemental report will be submitted.
 
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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 dr, suite 100
aliso viejo CA 92656
MDR Report Key12651476
Report Number3006179046-2021-00486
Device Sequence Number11802582
Product Code HSB
UDI-Device Identifier00887517951601
UDI-Public887517951601
Combination Product (Y/N)N
Initial Reporter StateCA
Initial Reporter CountryUS
PMA/510(K) Number
K180503
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/18/2021
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? No
Operator of Device Health Professional
Device Model NumberPS10.0-80SJ265
Device Lot Number9112719
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 09/29/2021
Initial Report FDA Received Date10/18/2021
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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