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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 PS10.0-50B235
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 08/05/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device has not yet been returned for investigation nor were x-ray films provided to confirm the alleged event.Root cause is unknown at this time.
 
Event or Problem Description
Information was received that the nail was implanted and then removed upon noticing it was defective as the screw holes were flipped 90 degrees.No patient injury was reported.
 
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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 Key10492084
Report Number3006179046-2020-00383
Device Sequence Number14287116
Product Code HSB
UDI-Device Identifier00887517950741
UDI-Public887517950741
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K180503
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/03/2020
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 Model NumberPS10.0-50B235
Device Lot Number0071404AAA
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 08/05/2020
Initial Report FDA Received Date09/03/2020
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;
Patient Age15 YR
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