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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 13117535
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Pain (1994)
Date of Event 04/04/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
No product has been returned for evaluation as product remains in-situ.No radiographs were provided to confirmed the alleged event; however, after review of the reported information, the root cause can be attributed to use error.No nuvasive product caused or contributed to this event.No product return.
 
Event or Problem Description
On (b)(6) 2019, a patient underwent an interbody fusion procedure with posterior fixation at th10-s1 levels without reported issues.Post-operative, the patient experienced pain.As per reporter it was confirmed that a screw at left side of the s1 level was in contact with the nerve.On (b)(6) 2019, a revision procedure was performed replacing the s1 screw.
 
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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 Key8614200
Report Number2031966-2019-00194
Device Sequence Number1756667
Product Code NKB
UDI-Device Identifier00887517582768
UDI-Public887517582768
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
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/18/2019
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 Number13117535
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 04/18/2019
Initial Report FDA Received Date05/15/2019
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 Other;
Patient Age63 YR
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