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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE BONE TRANSPORT SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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NUVASIVE SPECIALIZED ORTHOPEDICS, INC. PRECICE BONE TRANSPORT SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number BT10-90SJ340-5
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Skin Discoloration (2074)
Date of Event 01/08/2021
Type of Reportable Event Serious Injury
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 was performed on (b)(6) 2021.As per the reporter, the surgeon observed black stains on the patient's skin.Tissue samples will be taken and results will be provided.There was no harm or patient injury reported.
 
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Brand Name
PRECICE BONE TRANSPORT 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 Key11281286
Report Number3006179046-2021-00112
Device Sequence Number14484551
Product Code HSB
UDI-Device Identifier00887517979797
UDI-Public887517979797
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K201567
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 02/08/2021
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 NumberBT10-90SJ340-5
Device Lot Number9111116AAA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 01/08/2021
Supplement Date Received by Manufacturer02/03/2021
Initial Report FDA Received Date02/04/2021
Supplement Report FDA Received Date02/08/2021
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 Hospitalization; Other;
Patient Age35 YR
Patient Weight90
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