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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 BT10-10SJ380-7
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 11/28/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation.Culture results have been requested.No root cause can be confirmed at this time.
 
Event or Problem Description
Information was received that a revision procedure was performed on (b)(6) 2019.As per reporter, the patient was exhibiting wound seepage.At this time the cause and nature of the infection is unknown.
 
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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
suite 100
aliso viejo CA 92656
MDR Report Key9506662
Report Number3006179046-2019-00185
Device Sequence Number1410593
Product Code HSB
UDI-Device Identifier00887517980861
UDI-Public887517980861
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K182170
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 12/20/2019
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 NumberBT10-10SJ380-7
Device Catalogue NumberBT10-10SJ380-7
Device Lot Number9042506AAA
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 12/01/2019
Initial Report FDA Received Date12/20/2019
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 Age41 YR
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