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

Model Number	8800000
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device has been returned for evaluation nor have radiographs or images provided to confirmed the alleged malfunction.Label review: ".Potential adverse events and complications: potential risks identified with the use of this system, which may require additional surgery, include: bending, fracture or loosening of implant component(s)." ".Failure to final-tighten the lock screws with the counter-torque and torque t-handle may result in rod not able to normalize to the tulip.All lock screws should be final-tightened with the counter-torque and torque t-handle.Do not final-tighten through other instruments in the set." ".Care should be taken to insure that all components are ideally fixated prior to closure." ".Failure to verify screw height following insertion may result in screw heights not matching lordosis of the patient.All heights of screws should match with patient¿s lordosis to facilitate the best rod normalization when securing lock screws.".
Event or Problem Description
On an unknown date a patient underwent a single level posterior fixation procedure with no reported issues.Post-operative, a set screw was identified as detached.On (b)(6) 2020 a revision procedure took place.No patient injury reported.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Common Device Name: THORACOLUMBOSACRAL PEDICLE SCREW SYSTEM
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 9794715
• Report Number: 2031966-2020-00034
• Device Sequence Number: 2185268
• Product Code: NKB
• UDI-Device Identifier: 00887517344076
• UDI-Public: 887517344076
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K122352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8800000
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 03/05/2020
• Patient Sequence Number: 1