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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 PS10.0-80B265
Medical Device Problem Code Corroded (1131)
Health Effect - Clinical Code Osteolysis (2377)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device was not made available for evaluation.The root cause is unable to be determined.If any additional information is provided, a supplemental report will be submitted.
 
Event or Problem Description
Information was received that the nail was revised due to osteolysis observed via x-ray.In addition, pictures provided by the surgeon reveal corrosion on the nail.
 
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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 Key12232686
Report Number3006179046-2021-00416
Device Sequence Number17144470
Product Code HSB
UDI-Device Identifier00887517950765
UDI-Public887517950765
Combination Product (Y/N)N
Initial Reporter CountrySN
PMA/510(K) Number
K180503
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source distributor,foreign,health pr
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 07/27/2021
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? Yes
Operator of Device Health Professional
Device Model NumberPS10.0-80B265
Device Lot Number0011645AAA
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 07/05/2021
Initial Report FDA Received Date07/27/2021
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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