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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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NUVASIVE NUVASIVE RELINE SYSTEM; THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 16024545
Medical Device Problem Code Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code Device Embedded In Tissue or Plaque (3165)
Date of Event 04/09/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation as product remains in-situ.No allegation of product malfunction was alleged.No x-ray films were provided to confirm the event.
 
Event or Problem Description
On (b)(6) 2019, patient underwent an percutaneous posterior spinal fusion procedure at t11-t12 and l3-l4 levels without any reported issues.Post-operative images revealed that a portion of the reduction tube remained at l4 level screw.A revision procedure was performed and the portion of the reduction tube was removed.Not patient injury reported.
 
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Brand Name
NUVASIVE RELINE SYSTEM
Common Device Name
THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
Manufacturer (Section D)
NUVASIVE
7475 lusk boulevard
san diego CA 92121
MDR Report Key8584661
Report Number2031966-2019-00188
Device Sequence Number19423040
Product Code NKB
UDI-Device Identifier00887517555915
UDI-Public887517555915
Combination Product (Y/N)N
Initial Reporter CountryJA
PMA/510(K) Number
K143684
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/11/2019
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 Number16024545
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 04/11/2019
Initial Report FDA Received Date05/06/2019
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 Hospitalization;
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