MAUDE Adverse Event Report: NUVASIVE, INC NUVASIVE PRECEPT SPINAL SYSTEM; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE

Model Number	8847150
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Slipped (1584)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation of the radiograph confirms the reported event.There is no plan for a revision surgery at this time.No further evaluation of the product can be completed at this time.The root cause of this reported event has not been determined.Labeling review notes the following: "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, fracture of the vertebra".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.Ensure there is enough rod overhang when final tightening, and do not lock down on the conical portion of the rod.Failure to do so may lead to improper lock down of the construct.It may be necessary for the surgeon to add length to the rod, depending upon the patient anatomy and desired lordosis".Device remains in-situ.
Event or Problem Description
On (b)(6) 2016, a (b)(6) year old male underwent 4-level interbody fusion l2-s1 with bilateral posterior pedicle screw instrumentation.Around 3 months postoperative, it was noted a rod reportedly migrated and multiple lock screws seem to be loose.

• Brand Name: NUVASIVE PRECEPT SPINAL SYSTEM
• Common Device Name: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DEGENERATIVE DISC DISEASE
• Manufacturer (Section D): NUVASIVE, INC; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 5743256
• Report Number: 2031966-2016-00051
• Device Sequence Number: 10770639
• Product Code: NKB
• UDI-Device Identifier: 00887517378309
• UDI-Public: 00887517378309
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K122352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/21/2016

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: 8847150
• 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: 05/24/2016
• Initial Report FDA Received Date: 06/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR