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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INC NUVASIVE PRECEPT SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
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NUVASIVE, INC NUVASIVE PRECEPT SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 05/17/2017
Event Type  Death  
Manufacturer Narrative
No allegation of product malfunction reported.Although root cause cannot be determined, information suggest that patient's pre-existing condition may be a contributing cause.No radiographs nor product have been returned for evaluation.
 
Event Description
On (b)(6) 2017, a (b)(6) y/o female patient underwent a posterior spinal fusion at the t12-s1 levels.It was reported the surgery went well; however, the patient's condition worsened after surgery and later expired.No allegation of product malfunction.
 
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Brand Name
NUVASIVE PRECEPT SPINAL SYSTEM
Type of Device
ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
Manufacturer (Section D)
NUVASIVE, INC
7475 lusk blvd
san diego CA 92121
Manufacturer (Section G)
NUVASIVE, INC
7475 lusk blvd
san diego CA 92121
Manufacturer Contact
kim mccaleb
7475 lusk blvd
san diego, CA 92121
8589091980
MDR Report Key6638670
MDR Text Key77496762
Report Number2031966-2017-00070
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K122352
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial
Report Date 06/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age70 YR
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