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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number P12.5-80E245
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code Failure of Implant (1924)
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.Root cause is unable to be determined at this time.
 
Event or Problem Description
Information was received that a revision procedure is planned for (b)(6) 2020.As per the reporter, the nail seems to have stopped lengthening.No patient injury was reported.
 
Event or Problem Description
Report has been updated for correction of reported explant date.Information was received that the nail was not explanted during the revision procedure.The patient is still transporting and is in good condition.
 
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Brand Name
PRECICE 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 Key10893011
Report Number3006179046-2020-00479
Device Sequence Number2894992
Product Code HSB
UDI-Device Identifier00812258020897
UDI-Public812258020897
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K191336
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 11/30/2020
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 NumberP12.5-80E245
Device Lot Number0032505AAA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 10/26/2020
Supplement Date Received by Manufacturer11/25/2020
Initial Report FDA Received Date11/24/2020
Supplement Report FDA Received Date11/30/2020
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 Hospitalization;
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