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

Model Number	8800000
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No radiographs or images depicting the event have been received.Review of the device history records of explanted devices notes no material nonconformances with respect to material type, treatments or dimensions that may have caused or contributed to this event.Parts met acceptance criteria upon release.Explanted devices were examined and viewed markings are consistent with incomplete mating of components (normalization).The cause of the lock screw loosening is unclear; no malfunction of instrumentation is known to have occurred.Labeling 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), loss of fixation." warnings, cautions and precautions: ".Confirm heights of screws match with patient's lordosis when securing lock screws.Failure to verify screw height following insertion may result in inadequate rod normalization." ".Final-tighten all lock screws with the counter-torque and torque t-handle.Do not final-tighten through other instruments in the set, as the rod may not be able to normalize to the tulip.".
Event or Problem Description
On (b)(6) 2017 a patient underwent a posterior fixation procedure as an addition to an existing construct at l2-l5.During the procedure it was observed that locks screws in the existing construct had loosened.The existing construct was removed and replaced with the additional levels without reported issue.No injury has been 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: 6543323
• Report Number: 2031966-2017-00048
• Device Sequence Number: 97830
• Product Code: NKB
• UDI-Device Identifier: 00887517344076
• UDI-Public: 00887517344076
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K122352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/03/2017

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: Physician
• Device Model Number: 8800000
• Device Lot Number: NU5229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 05/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1