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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 P10.7-50A215
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 10/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
The device has not been returned for evaluation.X-rays provided confirmed the alleged event.Root cause is unable to be determined at this time.The reported event is addressed in the device labeling.
 
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2020.As per the reporter, the nail broke 1 year after implantation.No patient injury was reported.
 
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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 Key11033934
Report Number3006179046-2020-00510
Device Sequence Number1023462
Product Code HSB
UDI-Device Identifier00812258020057
UDI-Public812258020057
Combination Product (Y/N)N
Initial Reporter CountryAU
PMA/510(K) Number
K191336
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/14/2020
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 NumberP10.7-50A215
Device Lot Number8043001-AAA
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 11/23/2020
Initial Report FDA Received Date12/17/2020
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;
Patient Age24 YR
Patient Weight40
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