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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NUVASIVE, INC. NUVASIVE PRECEPT SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM

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NUVASIVE, INC. NUVASIVE PRECEPT SPINAL SYSTEM THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM Back to Search Results
Model Number 8890000
Device Problem Detachment Of Device Component (1104)
Patient Problem Failure of Implant (1924)
Event Date 05/07/2018
Event Type  malfunction  
Manufacturer Narrative
A review of radiographs has been performed. The evaluation of the explanted device found markings that indicate an incomplete assembly in-situ causing the post-operative disassembly. The patient remains asymptomatic. Review of the device history record notes no material nonconformance's, no manufacturing errors, nor discrepancies with respect to material type, treatments, dimensions that may have caused or contributed to this mode of failure. Parts met acceptance criteria upon release. Labeling review: "warning and cautions and precautions, potential risks identified with the use of this device system, which may require additional surgery include: device component fracture, bending or loosening of implant, loss of fixation, fracture of the vertebra and visceral injury. If healing is delayed, or does not occur, the implant may eventually loosen, bend or break. Loads on the device produced by load bearing and by the patient's activity level will dictate the longevity of the implant. " "care should be taken to insure that all components are ideally fixated prior to closure. All implants should be used only with the appropriately designated instrument (reference surgical technique). ".
 
Event Description
On (b)(6) 2018 a patient underwent a transforaminal lumbar interbody fusion procedure at l5-s1 levels with no issues reported. On (b)(6) 2018 during follow up radiographs revealed a tulip separation at the s1 right side level. On (b)(6) 2018 a revision procedure was completed where the screw was replaced with no additional issue reported. No patient harm or injury reported.
 
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Brand NameNUVASIVE PRECEPT SPINAL SYSTEM
Type of DeviceTHORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
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
george panfili
7475 lusk blvd
san diego, CA 92121
8588825019
MDR Report Key7567682
MDR Text Key110043386
Report Number2031966-2018-00094
Device Sequence Number1
Product Code NKB
UDI-Device Identifier00887517385604
UDI-Public00887517385604
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122352
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8890000
Device Lot NumberJP15166
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/19/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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